Industries.
Pharma Consulting.
Our specialized Pharma Consulting Services support you along the entire pharmaceutical value chain.
Individual?
We offer customized solutions, precisely tailored to your requirements in development, approval and production.
Compliant?
Our experts will guide you safely through all the regulatory requirements of the EMA, FDA and ICH guidelines.
Efficient?
Optimize your processes sustainably and bring your products to market quickly and successfully.
Ensure the success of your pharmaceutical projects.
Pharma Consulting - precise, compliant and efficient.
Our specialized Pharma Consulting Services provide you with targeted support in the optimization of pharmaceutical processes and the successful introduction of new drugs.
Our experienced consultants develop tailor-made solutions to meet the exact requirements of the pharmaceutical industry - from the initial development phase to approval and efficient production. We reliably meet the regulatory requirements of international authorities such as the EMA and the FDA as well as the standards of the ICH guidelines and GxP compliance.
With Entourage, you benefit from our in-depth industry knowledge and practical advice that sustainably improves your processes and minimizes regulatory risks. Our experts support you in optimizing production processes according to the latest quality standards in order to place your products faster, safer and more efficiently on global markets.
Take advantage of our experience to secure your long-term competitiveness, efficiently implement regulatory requirements and complete your pharmaceutical projects quickly and successfully.
Our areas of expertise in Pharma Consulting.
Our pharma consulting expertise covers all relevant areas to ensure that you comply with regulatory requirements, optimize processes and bring innovative products to market.
Regulatory compliance & approvals.
- Preparation and submission of regulatory dossiers (CMC, Clinical, Nonclinical)
- Strategic regulatory planning for global approvals (FDA, EMA, international authorities)
- Lifecycle management and support for Health Authority Interactions (HAI)
- Implementation and review of risk management systems (ICH Q9)
- Support with regulatory issues (variations, renewals, line extensions)
Quality management & process optimization.
- Development and optimization of quality management systems (GMP, GDP, GCP)
- Efficient CAPA processes (Corrective and Preventive Actions) and SOP development
- Implementation of GxP audits, mock inspections and preparation for inspections by authorities
- Process optimization through lean methods and Six Sigma principles in pharmaceutical production
- Support with technology transfers and scale-up projects
Clinical trials & pharmacovigilance (PV).
- Planning and management of clinical trials (GCP compliance)
- Medical affairs and medical writing (study protocols, CSR, investigator brochures)
- Support for audits and GCP inspections by health authorities
- Signal detection, Qualified Person for Pharmacovigilance (QPPV) and PV system management
- Optimization of clinical data management processes and quality assurance
Digitization & data management.
- Implementation of regulatory compliant data management systems (Data Integrity, 21 CFR Part 11)
- Introduction of digital quality management solutions to optimize your processes
- Use of AI-supported tools for more efficient and safe processes in R&D and production
- Development and implementation of digital strategies to comply with international regulatory standards
- Advice on cybersecurity and data protection in the pharmaceutical industry
Discover our Life Sciences expertise.
Research and Development and Engineering
We support your product development with innovative solutions for design, validation and implementation.
Clinical and Medical Affairs
We offer comprehensive expertise in study management, risk assessment and market surveillance.
Quality Management and Operational Excellence
We optimize your processes to increase efficiency and ensure the highest quality standards.
Business Data Solutions & IT Services
We create sustainable strategies and optimize your IT processes for maximum efficiency.
Manufacturing and Supply Chain Management
We develop solutions for efficient production and smooth supply chains.
Regulatory and Compliance
We navigate you safely through complex regulatory requirements and audits.
Successful consulting projects in pharma consulting.
Our case studies show how Entourage has supported pharmaceutical companies in process optimization and regulatory compliance and sustainably improved their projects.
Optimization of quality management and GxP audits
Technology transfer and lean manufacturing in production
Regulatory support and dossier submission
Clinical quality assurance and GCP inspections
Challenge.
A medium-sized pharmaceutical company was struggling to bring its quality management processes into line with GxP (Good Manufacturing Practice) requirements. This led to delays in audits and an increased risk of compliance violations.
Measures.
- Implementation of a robust quality management system (QMS) to comply with GxP guidelines.
- Implementation of training courses on CAPA management (Corrective and Preventive Actions) and the development of standardized operating procedures (SOPs).
- Preparation for audits through simulated inspections, including comprehensive risk assessments.
Results.
- 100% compliance with GxP audits without any complaints.
- 20% shorter preparation time for GxP inspections thanks to efficient SOPs and CAPA processes.
- Improved auditability and reduced risk of compliance violations.
Success.
The medium-sized company was able to significantly improve its audit capability and fulfill all GxP compliance requirements without any complaints.
Meet regulatory requirements efficiently.
Comprehensive pharma consulting services at a glance.
Our specialized pharma consulting services offer you comprehensive support along the entire product life cycle - from development and regulatory approval to successful market launch. We help you to precisely meet regulatory requirements, sustainably optimize your production processes and make targeted use of innovative technologies.
Our experts assist you in meeting all regulatory requirements and support you in preparing and submitting dossiers to international health authorities such as the EMA (European Medicines Agency) and the FDA (Food and Drug Administration). We provide you with comprehensive advice on ICH requirements and ensure efficient implementation of your risk management in accordance with ICH Q9 in order to identify and minimize regulatory risks at an early stage.
In the area of quality management, we support you in implementing reliable GxP-compliant quality management systems (QMS). Our experts develop efficient CAPA processes (Corrective and Preventive Actions) and optimize your SOPs (Standard Operating Procedures). Using lean methods and Six Sigma approaches, we increase the efficiency of your processes and reduce your production costs in the long term.
We support you in implementing modern data management systems that meet the regulatory requirements of FDA 21 CFR Part 11 and at the same time reliably implement data protection guidelines such as the GDPR. Our solutions include advanced data analytics and AI-based approaches to make your processes safer, faster and more efficient.
Innovation and speed are of central importance in the pharmaceutical industry. We support you in the strategic introduction of new technologies, accompany your technology transfer from research to industrial production and optimize your development processes. Our experts ensure that your pharmaceutical products are accompanied efficiently, regulatory compliant and successfully from the laboratory to market launch.
Get to know our experts.
Get in touch with our experts from the pharmaceutical industry.
Dr. Nils Sunder-Plassmann
Head of Pharma
Andreas Weirich
Head of Pharma Sales
Patrizia Piscopiello
Principal Consultant
