We are open to new things. Always remain authentic. With a high degree of flexibility. Passionate about our work every day. Transparent in our actions at all times. Credible and reliable.
Moritz Haucke, M.A. is the founder and Managing Partner of Entourage GmbH. He studied Information Science, Business Administration and Philosophy at Saarland University and looks back on many years of experience in HR consulting.
For a leading Anglo-Saxon recruitment company, Mr. Haucke successfully built up new markets in German-speaking countries and was subsequently responsible for the pharmaceutical sector for the D/A/CH region. Accordingly, he has excellent knowledge of GxP-regulated markets and an excellent network of experts and decision-makers within the pharmaceutical industry.
Moritz Haucke is Managing Director of Entourage GmbH and member of the Board of Directors of Entourage Pharma Consulting AG.
Dominik M. Aumer
Dipl.-Kfm. Dominik M. Aumer is an independent management consultant and founder of Entourage GmbH. He studied business administration at Saarland University and looks back on more than ten years of experience in strategic consulting and human resources development.
Mr. Aumer has deep knowledge in sales-related personnel and organisational development and an excellent network to decision makers and experts in the service industry. With the process-based method of Sales Process Consultancy that he developed, he designed scientifically sound concepts for sales personnel development as a consultant to sales organisations. In 2013 he was also voted one of the Top 100 Trainers Excellent in Germany.
Dominik M. Aumer is Managing Director of Entourage GmbH and a member of the Board of Directors of Entourage Pharma Consulting AG.
Kris Hofmann, Dipl- Kfm, studied business administration at Saarland University with a focus on human resources management, trade and marketing.
During his professional career, Mr Hofmann has already gained relevant experience in the field of strategic planning and strategic purchasing as well as in finance and budgeting with a focus on the retail sector. In addition, he has experience in the area of human resources and completes his profile with his sales knowledge.
As Head of Finance at Entourage, Kris Hofmann is responsible for the areas of contract design as well as accounting and controlling.
Anna Laube completed her Bachelor's degree in Professional Accounting Financial HIK and trained as a financial accountant. She also holds the title of Handelsfachwirt.
During her professional career, Ms. Laube gained practical experience at various companies. She has in-depth knowledge of accounting and financial bookkeeping.
Anna supports Entourage as Senior Account Manager.
Mariya Kovaliova studied business administration at the Rosenheim University of Applied Sciences. She focused on human resources management, digital marketing and international business law.
Ms. Kovaliova gained her first professional experience in the corporate human resources department of an international automotive manufacturer in Munich. There she worked primarily in HR process and quality management. Later, she supported the Corporate HR Strategy and Targets department in the New York metropolitan area, USA. Here she supervised and coordinated the strategic HR departments of the markets in North and South America. Most recently, she worked as a human resources officer for a security solutions service provider. Her responsibilities included co-establishing the HR department, recruiting, onboarding, training, training materials and payroll.
Mariya Kovaliova supports Entourage as an HR Business Partner.
Markus Meinke studied Business Administration in the dual system at the Beuth University of Applied Sciences in Berlin. He has already worked as an intern at Entourage in the areas of administration, marketing and research. Mr. Meinke also gained several years of experience in Human Resources, Administration and Finance.
Markus Meinke supports Entourage as Finance Manager.
Christina Schwenker studied business administration and management with a focus on human resources in Osnabrück. She gained her first experience in recruiting during her studies. Immediately after graduating, she completed a trainee program in human resources and thus succeeded in starting her career as a junior personnel officer. After the move, Ms. Schwenker worked in recruiting at an internationally renowned personnel service provider in Munich. There, she focused on filling specialist and management positions and was also responsible for employee support. At Entourage, Ms. Schwenker joined the HealthCare team after her parental leave. There she was responsible for the placement of medical specialists. After an internal transfer, she now devotes her time to human resources at Entourage.
Christina Schwenker supports Entourage as HR Business Partner.
Franziska Bellot attended an academy for sports, gymnastics and dance.
In addition to customer advertising and acquisition, Ms. Bellot was able to gain valuable experience in dealing with people, their leadership and motivational techniques as a gymnastics and fitness trainer. She also learned a lot about convalescents, healing processes and dealing with pain as a gymnastics and nutrition consultant in rehab. Subsequently, Ms. Bellot was in sales at Entourage for 4+ years, responsible for customer acquisition and support in medical technology. She also led an internal project to implement a learning management system and customized it to meet the needs of the organization. In her current role, she is expanding the Learning & Development program based on the company's strategy. She has extensive knowledge in sales, project management and people development.
Franziska Bellot supports Entourage as Learning & Development Manager.
Yulia Zolotova completed her Bachelor's degree in Management at the Higher School of Economics in Nizhny Novgorod, Russia.
She has extensive experience in payroll processing and customer service. In her previous position, she was responsible for the independent preparation of payroll accounting. She was also responsible for registering tax and social security contributions and coordinating communication with the authorities and health insurance companies.
Yulia supports Entourage as HR Payroll Manager.
Joanna Milewska has excellent organizational skills. She is successfully responsible for fleet management, optimizes onboarding and offboarding processes and ensures efficient telephony communication within the company. Her contribution is crucial to the smooth running of the office and she has a deep understanding of the team's needs. Joanna is the driving force behind an efficient office environment and is instrumental in making everything work.
Joanna Milewska supports Entourage as Office Manager.
Moritz Weber studied German, English and History at the Otto Friedrich University in Bamberg and the Ludwig Maximilian University in Munich. During his studies, Mr. Weber gained experience at a large, German private television broadcaster in the area of research & acquisition, especially in database work, research & analysis, consolidation of programme data and maintenance of content and products. He also gained initial experience in project management and in translating guides for employees into English. He also worked for a daily newspaper in the area of state politics and gained basic knowledge of journalistic work there, including researching & writing short messages and articles.
Moritz Weber supports Entourage as Marketing Manager.
Celine Karakaya completed her Bachelor in Global Brand & Fashion Management and is currently doing her Master in Marketing & Communication.
Ms. Karakaya gained several years of experience in an agency with a focus on PR & Social Media. She has strong skills in planning and executing marketing campaigns and designing workshops. She also has experience in independent communication and marketing conception as well as content creation on various platforms.
Celine supports Entourage as a working student in marketing.
Knut Schwarz trained as a medical-technical assistant at the Philipps University in Marburg.
During his professional career, Mr Schwarz worked for renowned pharmaceutical companies, research institutions and IT companies in an international environment. He has worked for the Human Genome Project, in research and development, technical IT support and site engineering. His long-standing portfolio includes the development of molecular biological methods, laboratory organisation and automation and process development and optimisation under GMP. In addition, Mr Schwarz is experienced in the development of laboratory databases and in the qualification and technical support of analytical equipment.
Knut Schwarz supports Entourage as Management Consultant.
Mohamed Omar is currently studying Digital Technology and Management at Bachelor level.
He is an experienced IT system administrator with extensive experience in administering hardware and ensuring network security. He has expertise in system administration and has successfully provided technical support to various companies.
Mohamed Omar supports Entourage as an IT system administrator.
Patrizia Piscopiello studied German language and literature, Italian studies, pedagogy and didactics as well as general linguistics at the University of Konstanz. She also successfully studied business psychology.
At the beginning of her professional career, Ms Piscopiello gained experience in public relations in the public sector and in corporate marketing at an SME. Until February 2016, Ms Piscopiello worked at Entourage as Assistant to the Managing Partners, where she was responsible for Entourage's office management and human resources management. Subsequently, Ms Piscopiello moved into sales as a staffing services provider in the pharmaceutical industry.
Patrizia Piscopiello supports Entourage as Principal Consultant.
Dr. Nils Sunder-Plassmann
Dr. Nils Sunder-Plassmann studied chemistry at the University of Manchester Institute of Science and Technology (UMIST) and the Karlsruhe Institute of Technology (KIT). At the University of Leipzig, he completed his doctorate in natural sciences at the Institute of Organic Chemistry on angiogenesis inhibitors as active agents in oncology. He also completed a postgraduate course at the Faculty of Medicine to qualify as a "Specialist Chemist in Toxicology".
During his more than 20-year career, Dr. Sunder-Plassmann has held various roles and management positions in consulting for the pharmaceutical industry and research and development. He has extensive experience in regulatory affairs, clinical development and project management. His core competencies include international drug approvals, process and risk management.
Dr. Nils Sunder-Plassmann supports Entourage as Head of Pharma.
Dr Natalie Berron
Natalie Berron studied biology at LMU Munich with a focus on molecular biology, cell biology and medical microbiology. She also received her doctorate in biology from LMU Munich, specialising in molecular biology and biochemistry.
During her professional career, Dr Berron worked in the pharmaceutical sales force. Her tasks included advising general practitioners, general practitioners and internists in the indications COPD and asthma, diabetes, hyperuricemia and shingles, as well as advising specialists in pulmonology in the indications COPD and asthma. She also organised events and conducted workshops and training for doctors and healthcare professionals. She was responsible for successfully increasing sales of the medicinal products for which she was responsible in the relevant territory and acted as a contact person for specialist medical questions, as well as an interface between marketing/medicine and external stakeholders.
Dr Natalie Berron supports Entourage as Senior Consultant Medical, Clinical and Safety.
Melissa Rieder completed an apprenticeship as a bank clerk. Later she studied business management at the University of Applied Sciences in Kufstein, Tyrol.
During her professional career, Ms. Rieder gained experience in supporting and advising private customers, in quotation and order entry, and in invoicing. Most recently, she worked in her family business as an assistant to the management.
Her activities there included the administration and organisation of day-to-day operations, all social media marketing activities, as well as the organisation and support of application processes. In addition, she worked as a project member in the company's merchandise management system.
Melissa Rieder supports Entourage as Assistant to the Management.
Dajana Radisic first trained as a state-certified sports and gymnastics teacher and is studying health and social management at the FOM University of Applied Sciences in Munich.
During her professional career in the sports and dance sector, Ms Radisic was already able to gain experience in dealing with people and their motivational mechanisms. Ms Radisic has excellent language skills in German, English and Bosnian.
Dajana Radisic supports Entourage at the Munich location as Consultant Pharma GMP.
Larissa Buvac successfully completed her degree in business psychology at the Fresenius University of Applied Sciences in Munich. During her studies, she specialized in market, advertising and media psychology in the sixth semester and in organizational psychology and consulting in the seventh semester.
Thanks to her many years of practical experience in sales and her degree in business psychology, Larissa Buvac has valuable knowledge and skills in customer service and sales.
Larissa Buvac supports Entourage as a working student in People Consulting.
Beatrice Weidinger first trained as an industrial clerk. She then studied business administration at the University of Applied Sciences in Munich and completed her bachelor's degree in business education at the LMU Munich.
Professionally, she first gained experience as an industrial clerk at a medical technology manufacturer. Later, she worked as a student trainee in the HR department of a global insurance company in Munich. Most recently, she worked for a personnel service provider. There she was responsible for the supervision of consultants in temporary employment, active participation in the recruiting process and the coordination and management of contract negotiations.
Beatrice Weidinger supports Entourage as Senior Consultant Pharma GMP.
Dr. Jennifer Neff
Dr. Jennifer Neff completed her training as a bank clerk at BHF Bank AG, Berlin. She then studied veterinary medicine at the FU-Berlin and wrote her doctoral thesis in primate genetics at the German Primate Center, Göttingen. Later she studied Business Administration at the FOM Hochschule für Ökonomie & Management, Berlin with a focus on quality management and process management.
After completing her doctorate, she first worked as a veterinarian, then moved to the medical technology, pharmaceutical and biotech industries. For more than 16 years, she has held various positions in regulatory affairs, clinical affairs and quality management. Her core competencies include international approvals of medical devices and pharmaceuticals, clinical trials, clinical evaluations, project management, process management, risk management, quality management systems and audits. In addition, she is active for the Regulatory Affairs Professional Society (RAPS) as Chair of the REC (RAPS European Council) and on the Board of RAPS Deutschland e.V..
Dr. Jennifer Neff supports Entourage as Head of Medical Devices.
Dr. Julia Beck
Dr. Julia Beck studied biology at the Ludwig-Maximilians-Universität in Munich and received her doctorate in medical microbiology and immunology.
As a doctoral student, she already worked together with industrial partners on in vitro diagnostics according to SOP specifications. Later, Dr. Beck worked as a consultant in the life science industry. There she was responsible for the complete recruitment process from candidate qualification to contract negotiations and candidate onboarding. As Branch Manager, Dr. Beck was then entrusted with the management of a branch office. She was responsible for the financial success of the branch as well as for ensuring recruitment strategies and the fulfillment of client orders. Most recently, as Scientific Lead Germany, she was responsible for the Scientific division on a national level.
Dr. Julia Beck supports Entourage as Head of Sales MedTec.
Dipl.-Ing. Sven Hoffmann studied biotechnology at the University of Applied Sciences in Bingen. He wrote his diploma thesis at the Rheinische Friedrich-Wilhelms-Universität Bonn.
Sven Hoffmann has 18+ years of experience in senior positions in IVD and medical devices. His positions have included Lead Auditor, Technical Expert and Certification Officer, Head of In-vitro Diagnostics, Global Head of Technical Competence Center IVD and Global Head Business Segment IVD. Most recently, he worked as Global Segment Manager IVD at TÜV Rheinland. His core competencies include quality management, project management, regulatory affairs, the IVDD and the IVDR.
Sven Hoffmann supports Entourage as Head of IVD.
Dr. Sebastian Grömminger
Dr. Sebastian Grömminger holds a diploma in molecular biology from Goethe University in Frankfurt am Main and conducted his PhD at Helmholtz Zentrum München.
Dr. Grömminger is an expert in in vitro diagnostic medical devices, quality management, regulatory affairs and risk management. He has extensive knowledge in software life cycle compliance according to EN (IEC) 62304 of usability according to EN (IEC) 62366, as well as experience in assay development and performance evaluation. As a consultant, he has conducted or led more than 30 successful projects for the regulatory approval of in vitro diagnostic products. As a lecturer in Regulatory Affairs, he has extensive expertise in IVD technical documentation, IVD detection and measurement methods, and the development of online training courses for the practical implementation of the IVDR.
Dr. Sebastian Grömminger supports Entourage as Principal Consultant IVD.
Michael Meyer graduated with a degree in sports science from the German Sport University Cologne in 2009.
During this time, Mr Meyer gained insights into the areas of sales & marketing at internationally operating groups in the automotive, aerospace and aeronautics industries through stations in Germany and abroad. After completing his studies, Mr Meyer gained his first experience in research and consulting as a consultant in the field of executive search. Further activities in sales on the corporate side as well as in the start-up sector round off his profile.
Michael Meyer supports Entourage at the Munich location as Senior Consultant MedTec.
After graduating in International Business Management from the European College of Business & Management in London, Isabella Winhart completed her training as an International Office Administrator with a focus on business administration at the state vocational school in Bad Tölz-Wolfratshausen.
Ms Winhart has more than three years of professional experience with a large German car rental company and gained knowledge in project management, event organisation and office communication in addition to international experience in England and France.
Isabella Winhart supports Entourage as Consultant MedTec.
Ivan Zivkovic studied business administration and business psychology in the Bachelor of Science at the FOM University of Applied Sciences in Munich.
During his vocational training at a health insurance company as an insurance and finance clerk, Mr. Zivkovic was able to gain initial customer care and sales experience. In addition to his studies, Mr. Zivkovic gained experience in the areas of marketing, sales, customer care service and quality management in working student positions. Most recently, Mr. Zivkovic worked as a recruitment consultant for a personnel service provider. His core competencies include the acquisition of new customers, the qualification of candidates, as well as the all-round support of candidates and customers.
Ivan Zivkovic supports Entourage as Senior Consultant MedTec.
Jakub Raster completed his studies in Political Science / Sociology at the LMU Munich. He is currently studying business education for a bachelor's degree.
During his professional career, Mr. Raster was already able to gain experience in various working student positions. Among others, he worked at a public television station as a technical assistant and at the Consulate General of the Republic of Poland as an intern. Furthermore, he worked for a real estate company as an assistant to the site manager. Mr. Raster also has very good language skills in English, French and Spanish.
Jakub Raster supports Entourage as Consultant MedTec.
Nikita Ivanov completed his training as an industrial clerk at Siemens AG / Unify Software & Solutions GmbH & Co. KG.
Mr Ivanov first gained professional experience at a software company for communication solutions and in internal sales at an ATM operator. He acquired skills in personnel consulting as a consultant for IT infrastructure. There he was responsible for the acquisition, pre-selection and support of candidates. Most recently, Mr Ivanov worked as a consultant for an international personnel service provider in the area of software development and IT infrastructure. His tasks included the identification, development and maintenance of customer relationships and the support of candidates throughout the entire application process.
Nikita Ivanov supports Entourage as Consultant MedTec.
Claus Myrou completed his training as a state-certified commercial assistant in the field of information processing. His specialisations included business administration, human resources, financial accounting and IT and systems application.
During his professional career, Mr Myrou first gained experience in retail as a sales assistant and branch manager trainee. Later, he worked as a clerk in initial processing at the Berufsgenossenschaft für Gesundheitsdienste und Wohlfahrtspflege.
Most recently, he was responsible there for new client admissions, checking and paying invoices, maintaining electronic files and providing support and advice to insured persons.
Claus Myrou supports Entourage as People Consultant MedTec.
Oliver Schons completed his education as IST Diploma Sport & Health Trainer and studies Sport Business Management on Bachelor.
Professionally, Mr. Schons gained experience as a personal trainer in various companies and areas. Among other things, he was responsible for customer acquisition and the support of existing customers. Most recently, he was responsible for receivables management. Here he was responsible for collection management and dunning, parts of controlling and correspondence with law firms. In addition, he acted as an advisor to the management and supervised projects with up to 20 employees.
Oliver Schons supports Entourage as People Consultant MedTec.
Johannes Preiss trained as a sports and fitness merchant (IHK) and sports and health trainer (IST) in Munich.
During his professional career, Mr. Preiss first gained experience as a tax secretary trainee at the State Tax Office in Munich. Here he was entrusted with the processing of tax documents for income tax, trade tax and corporate income tax, cooperation in garnishment and execution and the development of the legal order for tax processing. Most recently, he worked as a shift leader and assistant studio manager at a fitness studio. His duties included deputizing for the studio management, organizing and planning promotions, controlling current statistics and closing deals with new customers, planning and preparing duty rosters, and ordering and purchasing studio supplies.
Johannes Preiss supports Entourage as People Consultant.
Louis Harth is studying Business Administrations with a focus on International Management at ISM in Munich.
During his professional career, Mr. Harth worked in various positions and activities. Among other things, he worked as a test assistant and logistics manager at a Corona testing and vaccination center in Munich and in the catering industry. He also worked as a self-employed tutor. Furthermore, Mr. Harth completed an internship at BMW in the development department.
Louis Harth supports Entourage as People Consultant MedTec.
Marita Klafke holds a degree in business administration with a focus on healthcare and hospital management. In addition, she deepened her knowledge in business management, strategic management, financial management at Babson College, Massachusetts, USA and is a specialist nurse for anesthesia and intensive care medicine.
As a health care expert in international medical technology and hospital management, Ms. Klafke has more than two decades of experience in leadership, management, portfolio strategy and management. She also has excellent intuition for customer and patient benefits, market developments and trends, and has extensive experience and expertise in setting up and expanding profit centers, business units and subsidiaries. Her other core competencies include general management, business development, sales and marketing. She rounds off her profile, which is characterized by internationality, with several years of work in the USA, including managing a US medical technology company and participating in executive programs at a US university. In 2022, the Interim Management Provider Working Group (AIMP) presented Ms. Klafke with the "Interim Manager of the Year" award.
Marita Klafke supports Entourage as Head of Management Consulting (ad interim).
Dr Ralf Hess
Dr Ralf Hess studied biology at the Albert-Ludwigs-University of Freiburg and received his doctorate at the Institute of Virology. Dr. Hess has many years of experience in the development of medical devices and medicinal products as well as their combination, in laboratory analytics and their quality assurance. The quality expert has established, implemented and maintained QM systems according to ISO and GxP for various application areas. The customer service portfolio ranges from manufacturers of classical and biological drugs, medical device companies and vaccine manufacturers to immunohistochemical, immunological, molecular biological and serological diagnostic laboratories. Dr. Hess is active worldwide as an auditor in the GxP/ISO area and has many years of experience in FDA remediation projects and the regulatory development of combination products (drug device products).
Dr. Ralf Hess supports Entourage as Principal Management Consultant.
Antje Schroeter graduated from Saarland University with a degree in business administration. She is a trained business coach and holds various project management certificates, including a Project Management Professional (PMP®).
During her professional career, Ms. Schroeter first worked as a Supply Chain Manager, Project Manager and Program Manager for European companies in the aerospace industry. Most recently, she worked as an authorized signatory at one of the Big Four for global transformation projects in the pharmaceutical and healthcare sector in Hamburg and Munich. In addition to her focus on deal-related projects such as carve-outs and post-merger integrations, Ms. Schroeter has developed and trained in-house project management trainings on a national and international level together with her team of trainers.
Antje Schroeter supports Entourage as Principal Management Consultant.
Assoc. Prof. Dr Simon Schulz
Assoc. Prof. Dr. Simon Schulz received his diploma in chemistry from the Ruprecht Karls University of Heidelberg. He received his doctorate from the Institute of Physical and Biophysical Chemistry; Heidelberg, and the Max-Planck Institute for Intelligent Systems, Stuttgart. In 2016, he was appointed Associate Professor in Experimental Medicine by the University Medical Centre Freiburg.
Dr. Schulz has many years of experience in GLP compliance and computer validation as well as the development and testing of medical devices and combination products. He has extensive expertise in the compliance of medical devices with ISO 13485 and FDA 483 according to 21 CFR 820 and the development of compliant SOPs for their design and manufacturing process. Furthermore, he has distinct competence in CAPA management, complaint handling and process validation. He is lecturer for quality of medical devices and medicinal products at the University Freiburg, Faculty for Chemistry & Pharmacy.
Dr. Simon Schulz supports Entourage as Senior Management Consultant.
Ulrike Heimann is a graduate engineer (FH) in electrical engineering / mechatronics. In addition, she completed an MBA in International Business Management.
Ms. Heimann has 10+ experience in the pharmaceutical industry. She is an experienced project manager, including cleanroom construction in pharmaceutical, semiconductor and electrical industries, as well as development and qualification of cleanroom monitoring systems (SCADA).
She has also successfully managed infrastructure projects in the pharmaceutical environment both domestically and internationally. Additionally, she has excellent knowledge of national and international pharmaceutical standards such as ISO 14644, Annex 1 and 21CFRPart11 and qualification / validation according to FDA and GMP standards.
Ms. Ulrike Heimann supports Entourage as Senior Management Consultant.
Merlin Idris earned a bachelor's degree in business psychology. He then completed his master's degree in International Business. Meanwhile, he spent two semesters abroad in Mexico and the USA, one at the Tecnológico de Monterrey and one at Berkeley College in New York.
Mr. Idris has several years of professional experience in data-driven business model innovation and project management with a focus on digitalization. His core competencies include design thinking, Agile and Lean methodologies (Scrum and Kanban), and project management. He supported consulting projects in the areas of digitalization, data analytics, HR and IT, among others.
Merlin Idris supports Entourage as a manager.
Dirk Düsterhöft studied computer science at the University of Applied Sciences in Bremerhaven with a diploma in media informatics. Mr Düsterhöft also holds a Master's degree in Management with a focus on Corporate Management from FOM Bremen.
During his professional career, he has worked in various positions such as Online Media Manager, Coordinator for Systems and Databases and as an IT Analyst. His core competencies include the recording and analysis of CSV-relevant processes in vaccine production as well as the coordination of the migration of software systems validated according to GMP, including revalidation. Furthermore, he is experienced in CSV in the entire production area (GxP, GAMP5, V-Model, Lean, PDSA, ITIL) and in process optimisation and implementation of international CSV company specifications. Mr Düsterhöft took over a CSV project in the SAP environment with more than 25 key users as project manager and successfully completed it in terms of quality, time and costs.
Dirk Düsterhöft supports Entourage as Senior Management Consultant.
Constantin Stihl completed his Bachelor's degree in General Management at the EBS University of Economics and Law in Oestrich-Winkel. Mr Stihl completed his Master's degree in Management and Technology at the Technical University of Munich, interrupted by a stay abroad at Bocconi University in Milan at the Department of Management and Technology.
During his studies, Mr Stihl gained professional experience in various industries. In addition to internships in a strategy and management consultancy as well as in an auditing and tax consultancy, he also worked in various areas of banking, including operations, client management, controlling and asset management. Most recently, he co-founded an app that provides patients with equal access to quality testing and healthcare through digital technology.
Constantin Stihl supports Entourage as Management Consultant.
Felix Mundt studied Tourism and Hotel Business Administration at the Universidad Dominica O&M in Puerto Plata in the Dominican Republic.
Mr. Mundt is a management consultant with a focus on project and change management. He gained professional experience in logistics, purchasing, controlling and project management. His core competencies include project controlling, project reporting, IT project management, stakeholder and risk management. He gained project experience in project controlling in the area of logistics for the implementation of SAP S4/HANA at an OEM in the automotive industry, in project management for the integration of a new production site in Latin America for the central systems of the parent company and in project management for the conversion of a Customer Interaction Center for the German market of an OEM in the automotive industry. He has also been a lecturer in project management.
Felix Mundt supports Entourage as a Management Consultant.
Nhung Pham is studying Business Administration & Business Psychology at the FOM Munich with a focus on HR Management and Labour Law.
As a working student at a well-known HR consultancy, Ms Pham already gained experience in recruiting specialists and executives. She has knowledge in active sourcing in the management and implementation of the recruiting process. Furthermore, Ms Pham worked in the field of Business Intelligence & Administration in the IT industry. There she compiled relevant business information as a basis for operative and strategic decisions, she created reports and was responsible for performance and financial controlling.
Nhung Pham supports Entourage as Management Consultant.
Lars-Oliver Bolz studied chemistry at the ETH-Zurich and the Friedrich-Alexander-University in Erlangen.
During his studies, Mr. Bolz successfully founded a company with the aim of developing and selling transcutaneous vagus nerve stimulators for the non-pharmacological treatment of epilepsy and migraine. Among other things, Mr. Bolz was responsible for the research and development of new device concepts and as project manager of a BMBF funded project for the research of neurological diseases in children and adolescents. He also completed internships at the Max Planck Institute for the Physics of Light in Erlangen, as well as at several medical technology manufacturers in the areas of development, sales and controlling.
Lars-Oliver Bolz supports Entourage as Senior Management Consultant.
Dr. Lara Milakovic
Dr. Lara Milakovic studied chemistry at the Technical University of Munich and did her doctoral research there.
During her studies, she completed her master's thesis in the U.S. and gained her first professional experience as an intern at a global chemical and pharmaceutical company in the Strategic Innovation-Science Relations department, focusing on strategic partnerships and startup screening. Subsequently, she continued to work for the department on a part-time basis as a freelance consultant while working as a research assistant at the Technical University of Munich. There, Ms. Milakovic conducted research in the field of heterogeneous catalysis and was responsible for experimental design and execution, reactor setups, and analytical evaluations.
Dr. Lara Milakovic supports Entourage as Senior Management Consultant.
Charis Schmidt studied pharmaceutical biotechnology in her bachelor's degree at Biberach University. She also completed her master's degree in pharmaceutical biotechnology in a cooperation between Biberach University of Applied Sciences and the University of Ulm. In addition, Ms. Schmidt spent a semester abroad at the East China University of Science and Technology at the School of Bioengineering in Shanghai, China.
During her professional career, Ms. Schmidt worked as a quality auditor in the area of GMP and ISO at a well-known pharmaceutical company. Her responsibilities included internal audits, supplier qualifications and audits, preparation and supervision of customer audits and regulatory inspections.
Charis Schmidt supports Entourage as a Management Consultant.
Anastasia Wolf studied Biopharmaceutical Technology at the Technical University of Central Hesse in Giessen and graduated with a Bachelor of Science in 2015.
Among other positions, Ms. Wolf worked for a global player in in-vitro diagnostics and served as Head of Technical Documentation Regulatory Affairs. She has knowledge in technical documentation, the implementation of international approvals, medical device software IEC 62304, conformity assessments and data management. Ms. Wolf rounds out her profile with her excellent language skills in German, Russian and English.
Anastasia Wolf supports Entourage as Senior Project Consultant.
Ghandi Dissing holds a Bachelor's degree in Animal Biology and Pharmaceutical Engineering and is currently enrolled in an Executive MBA programme with a focus on Innovation Management and Entrepreneurship.
Having worked in both the pharmaceutical and medical device industries, Mr. Dissing has gained in-depth knowledge in validation and qualification of production processes/equipment, test methods, computer systems (CSV) and packaging lines in compliance with regulations (FDA, ISO 13485:2016) as well as validation protocols (IQ, OQ, PQ), reports and SOPs, risk assessments (FMEA's) and in GMP regulated environments. As a certified Lean Six Sigma Green Belt, he is experienced in process optimisation, process monitoring and waste reduction and has successfully implemented 5S concepts, KPI tools and GAP. He also has knowledge in design thinking, innovation management, lean management and project management.
Mr Ghandi Dissing supports Entourage as Project Consultant Validation Engineer.
Dr. Friederike Bieler
Friederike Bieler is a graduate engineer (FH) and holds a Master of Science in Biomedical Engineering. She later earned a doctorate in engineering at the TU in Berlin.
During her professional career, Dr Bieler first gained experience as a research assistant at the Julius Wolff Institute, Charité Berlin. She has 8+ years of experience in regulatory affairs in medical technology. As Senior Specialist Regulatory Affairs, she was most recently responsible for MDD/MDR Class IIb (implantable) and Class III (combination) products. She has in-depth knowledge of the MDD and MDR and has experience in assessing/supporting the preparation of clinical evaluations. Furthermore, she has knowledge in technical documentation, implementation of international marketing authorisations and ISO 13485.
Dr Friederike Bieler supports Entourage as Project Consultant.
Oliver Gann studied electrical engineering at the University of Darmstadt and graduated with a diploma.
Mr Gann is an experienced Project Consultant for Regulatory Affairs and Change Management with a focus on medical equipment. In the 25+ years of his professional career, he gained experience in the areas of procurement, production, quality management and regulatory affairs. His core competencies include in-depth knowledge and experience in global regulatory processes, practical knowledge and experience in change management, as well as the analysis and creation of processes within QM systems according to ISO 13485. During his last position as Senior Manager Regulatory Affairs, Mr. Gann was responsible for the representation of Regulatory Affairs in development projects, new registrations and the maintenance of existing registrations in the EMEA region, communication with the Notified Body, development of EU-wide submission strategies over the product life cycle of the product portfolio, including the MDD/MDR transition.
Oliver Gann supports Entourage as Project Consultant.
Maren Krämer first completed her Bachelor of Engineering with a focus on bioprocess engineering at the Frankfurt University of Applied Sciences.
She then went on to obtain her Master's degree in Biomedical Engineering at the Technical University of Central Hesse. Ms. Krämer gained professional experience in various internships, including at a pharmaceutical company in the area of production and batch record review. Most recently, she worked for a medical device company as a Regulatory Affairs Specialist. Her responsibilities included international regulatory approval, creation and maintenance of technical documentation and implementation of regulatory requirements.
Maren Krämer supports Entourage as a Project Consultant.
Dr Thomas Koblizek
Dr Thomas Koblizek studied biochemistry at the Eberhard Karls University in Tübingen and did his doctorate at the Max Planck Institute for Physiological and Clinical Research in Bad Nauheim.
Dr Koblizek has 20+ years of experience in the development of laboratory products, pharmaceuticals and medical devices as well as their quality assurance and quality management. During his professional career, Dr Koblizek has held positions including Head of Research and Development, Head of Laboratory and Director Regulator Affairs & Quality Assurance. The core competences of the quality expert include manufacturing and release documentation according to FDA requirements, the validation of processes and methods as well as the construction and qualification of production facilities (IQ, OQ, PQ). He is also experienced in the preparation and maintenance of technical documentation according to MDD and MDR (Class I-III) and in quality management according to ISO 13485.
Dr Thomas Koblizek supports Entourage as Senior Project Consultant.
Susanne Monka did her BSc (Hon) in Neuroscience at the University of St Andrews in Scotland. She then went on to do a Master of Science in Molecular Biology at the University of Oslo, Norway.
Ms Monka has experience in collecting and analysing data in the neuroscience and behavioural science fields. She has several years of research in the analysis of doctor-patient communication, focusing on pattern research with Theme (Noldus) and Observer (Noldus). In addition, Susanne has laboratory experience in crystallography, neurobehavioural research and physiological control of the spinal cord. This also includes general laboratory techniques such as qPCR, UV-vis spectroscopy, pipetting and chromatography.
Susanne Monka supports Entourage as Project Consultant.
Swen Ortinghorn studied production engineering and organisation (B.Eng.).
Professionally, Mr Ortinghorn gained experience as a plant planner and simulation user and project engineer in plant construction. His responsibilities here included project coordination between simulation, planning and design, the creation, elaboration and documentation of manufacturing concepts, process optimisation and elimination of design loops, as well as the realisation and optimisation of robot simulations for new and existing car body construction plants. Most recently, as a senior project engineer, he was responsible for strategic management consulting, virtual assembly planning of large-scale plants and special machines, the definition and installation of production facilities, and the construction and display of cells in virtual reality. He has also advised and supported numerous OEMs in the field of the digital factory.
Swen Ortinghorn supports Entourage as a Project Consultant.
Tony Gómez trained as an office management assistant. He is also a plant operator and manager of solid packaging plants in pharmaceutical GMP production, SOP author, quality assurance manager in pharmaceutical production and trainer for employee training in pharmacy and CSV.
Mr. Gómez has five years of professional experience in pharmaceutical GMP production and is an interface expert in pharmaceutical and IT QA topics. His core competencies include SOPs, CAPAs, CCs, deviation and complaint management, PMS, LMS, MES systems, SAP, Veeva, CSV (EU Annex 11), employee training and coaching, and training and curriculum management. He gained project experience in the implementation of a curriculum annual check, introduction of a SAP documentation module and an implementation of a Q-Doc and training software.
Tony Luis Gómez supports Entourage as a Project Consultant.
Marina Schmidt-Thomé did her bachelor's degree in chemistry and biochemistry at LMU Munich, where she also completed her master's degree in chemistry with a focus on physical and inorganic chemistry.
During her studies, she completed several research internships, including at the University of Alberta in Camrose, Canada, at the Department of Physical Chemistry at LMU and at the Walther Straub Institute for Pharmacology and Toxicology in Munich. She also completed basic courses in business administration and GMP. She gained professional experience as a laboratory assistant in the processing of human blood samples for omega-3 index determination via gas chromatography. Her skills include NMR spectroscopy, IR/Raman spectroscopy, UV/Vis spectroscopy and gas chromatography.
Marina Schmidt-Thomé supports Entourage as Project Consultant.
Dr. Nicole Affinass
Dr. Nicole Affinass studied Biosciences at the University of Potsdam and Biochemistry at the FU Berlin. Here she later also received her doctorate in biochemistry with a focus on immunology.
During her university career, she already gained experience as a research assistant and intern, for example in the biomedical field. During her subsequent training in Clinical Trial Management, Dr. Affinass gained experience in quality assessment of study-related documents, identification of quality risks and participation in audits. Most recently, she worked as a Regulatory Affairs Manager. Her responsibilities included ensuring and maintaining the registration of currently marketed products, planning and preparing change notifications, ensuring regulatory implementation of changes and timely submission of applications as well as regulatory inquiries, coordinating regulatory activities, and adapting patient information leaflets and labeling texts.
Dr. Nicole Affinass supports Entourage as a Project Consultant.
Christine König completed her training as a state-certified chemical-technical assistant at the Lise-Meitner-Schule OSZ in Berlin.
Ms König has 8+ experience as a chemical laboratory assistant at various global pharmaceutical companies, primarily in production according to GMP/cGMP guidelines. In addition, she has experience as a Subject Matter Expert, has knowledge in CMC Change Management and has theoretical and practical knowledge in instrumental analytics. As deputy shift supervisor, she was responsible for training and briefing new employees. In addition, Ms König was the CAPA, Change, Variance and Deviation Management Officer and responsible for updates and recreations of risk analyses (FMEAs) and the validation of new products in production.
Kristine König supports Entourage as a Project Consultant.
Dr Christopher Spiegel
Christopher Spiegel studied Biotechnology (B.Sc.) at the BA Riesa in cooperation with the Max Planck Institute for Molecular Cell Biology and Genetics, as well as Regenerative Biology and Medicine (M.Sc.) at the TU Dresden.
Dr Spiegel gained professional experience during his part-time doctoral studies at a GMP-certified biotech start-up. Afterwards, he was responsible for gap analyses of the technical documentation regarding biocompatibility with regard to MDR at a well-known medical technology manufacturer, among other things, and later led a team of MDR experts. He was also responsible for closing identified gaps by writing rationales or acting as a study monitor for conducting studies at external testing laboratories according to ISO 10993. Most recently, he supported a global MD manufacturer in developing a process challenge device for evaluating EO sterilisation and setting up a material database for evaluating biocompatibility according to MDR.
Dr Christopher Spiegel supports Entourage as Project Consultant.
Martina Brecelj studied biology at the LMU Munich.
She then worked there as a research assistant in prion research.
During her professional career, Ms Brecelj worked for a leading pharmaceutical company as a scientist in research and development and GMP department. There she was responsible for the development and establishment of analytical methods (SDS-PAGE, IEF) as well as for the validation of GMP compliant analytical processes. Furthermore, she was Quality Assurance Manager at a CRO in the quality assurance department responsible for supplier qualification, monitoring and implementation of CAPAs as well as the development of a QA system.
Martina Brecelj supports Entourage as a Project Consultant.
Michael Fellner trained as a chemical-technical assistant and studied chemistry at the University of Stuttgart.
Mr Fellner has several years of experience in medical technology (MDR, FDA, MDSAP,...) in the areas of QA, QM, RA and R&D. This includes the topics of qualification and validation, TMV, CSV, optimisation of QM and production processes, CAPA management, complaints, vigilance and other Q topics, including experience as an interim QA manager. He also has experience in the implementation and realisation of CAQ systems.
Michael Fellner supports Entourage as a project consultant.
Melanie Dauenhauer trained as a businesswoman for office communication and organisation. In addition, she completed a certificate course to become a Regulatory Affairs Manager and underwent further training in ISO 13485, post-market surveillance and internal audits for auditors in the medical device industry according to ISO 13485.
During her professional career in the field of Regulatory Affairs, she gained experience in the revision and maintenance of product files, country-specific approval, in quality management as deputy QMB, in the support of audits and in the revision and creation of processes. Most recently, she worked as a Technical Documentation & Clinical Evaluation Officer. Her tasks included the creation and maintenance of technical documentation and the creation and maintenance of clinical evaluation.
Melanie Dauenhauer supports Entourage as a Project Consultant.
Roberto Leyh first completed his training as a radio and television technician, followed by his master's degree in electrical engineering.
Mr Leyh has over 20 years of experience in the production sector and has extensive experience in electrical, medical and automotive engineering. He has worked as a project manager, product and quality manager and validation engineer. Most recently, he worked as Supplier Quality Support and was responsible for up to seven employees. In addition, Mr Leyh was responsible for supplier qualification and supplier audits (DIN EN ISO 9001) as well as for the evaluation of various quality assurance measures. In addition to process verification and validation, his core competences include product development and support, but also advance quality planning (APQP, FMEA, SPC, MFU).
Roberto Leyh supports Entourage as Project Consultant.
Natalie Müller studied Biotechnology in her Bachelor's degree and Chemical Technology in her Master's degree at Darmstadt University of Applied Sciences.
As a working student, Ms Müller gained initial experience in the development, optimisation and validation of analytical methods and in the production of pharmaceuticals.
During her professional career, she worked as a validation engineer and quality control manager of validation and in the area of GMP compliance. Most recently, the certified Quality Manager worked as a Specialist for Compliance Supply Chain Management at a renowned vaccine manufacturer. There she was responsible for the creation and revision of SOPs and verification master plans for transport verification and risk analysis. Further core competences of Ms Müller are the management of controlled documents (SOPs, CAPAs, changes, deviations) as well as the implementation of GMP-compliant method validations, technical documentation, data evaluations and system maintenance.
Natalie Müller supports Entourage as Project Consultant.
Björn Kolthoff completed vocational training as an industrial mechanic specialising in machinery and systems engineering at S.A.M. Schiffstechnik in Cuxhaven, followed by a part-time course of study to become a state-certified computer scientist at Bremerhaven University of Applied Sciences.
Mr Kolthoff has worked as a change control and QA manager, most recently as a QA senior specialist in the pharmaceutical industry. He has more than 20 years of experience in the GMP environment, more than 10 years in the production area of sterile drugs and vaccines and 7 years of experience in Change Control Management. In addition, he has undergone certified training ranging from QMB to quality auditor. Mr Kolthoff is experienced in conducting internal audits and accompanying external audits.
Mr Björn Kolthoff supports Entourage as Project Consultant.