Industries.
Pharma Consulting.
Compliant?
Holistic?
Efficient?
Ensure the success of your pharmaceutical projects.
Our core competencies in the pharmaceutical industry.
We support you in optimizing your pharmaceutical processes so that you can meet regulatory requirements efficiently and on time. With our support, you can ensure that your products not only meet the highest quality standards, but also receive the necessary approvals.
Whether preparing and conducting clinical trials, managing regulatory requests or implementing robust quality management systems, we can provide you with the strategic advice you need. Our goal is to successfully implement your projects from the planning phase to market launch by minimizing potential risks and maximizing efficiency.
With our holistic approach to pharma consulting, we support you at every stage, from regulatory compliance to clinical development and process optimization. Our consulting services cover all important aspects that are necessary for success in the pharmaceutical industry.
Discover our expertise in pharma consulting.
Quality management.
- Quality management & compliance
- CAPA management and SOP development
- GxP inspections and audits
- Qualification & validation
Manufacturing Science & Technology (MS&T).
- Technology excellence and clean supply chain operations
- Sustainability strategies for pharmaceutical production
- Technology transfer and lean manufacturing
- EHS (Environment, Health, Safety) and capability building
Regulatory Affairs.
- Regulatory strategy and CMC support (Nonclinical & Clinical)
- Life cycle management and dossier creation
- Communication with health authorities
Medical, Clinical, PV.
- Medical Affairs and Medical Writing
- Audits and GCP inspections
- QPPV and signal detection
- Sustainable clinical project management and monitoring during the recruitment and onboarding of laboratory specialists
Successful consulting projects in pharma consulting.
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.
Challenge.
A global contract manufacturer of pharmaceutical products needed to transfer technology and introduce lean manufacturing principles to reduce costs and optimize production processes.
Measures.
- Introduction of a comprehensive technology transfer program to optimize production lines and ensure product quality.
- Implementation of lean manufacturing principles to reduce waste, increase efficiency and shorten production times.
- Training staff in lean methods and continuous process improvement.
Results.
- 30% reduction in production costs through improved resource utilization and less waste.
- 40% shorter production times and faster time to market thanks to production line optimization.
- Improved production processes that increase the company's competitiveness in the long term.
Success.
The contract manufacturer was able to significantly increase production efficiency and reduce costs through technology transfer and the introduction of lean manufacturing principles.
Challenge.
A global pharmaceutical company had to meet complex regulatory requirements in several countries and submit the necessary dossiers on time to secure marketing authorization.Measures.
- Preparation of a detailed dossier management plan for submission in various regions.
- Coordination of communication with health authorities and support in responding to inquiries from authorities.
- Advice on adapting dossiers to regional regulatory requirements and specific market requirements.
Results.
- Timely submission of dossiers in all target markets.
- Reduction of queries from authorities by 25%, as the dossiers have been optimized and tailored to the respective requirements.
- Faster market approval and fulfillment of all regulatory requirements.
Success.
The global pharmaceutical company was able to streamline its regulatory processes and secure marketing authorization in several countries simultaneously.Challenge.
A mid-sized company specializing in clinical research faced challenges in complying with Good Clinical Practice (GCP) guidelines, particularly in preparing for inspections by global regulators.
Measures.
- Implementation of a comprehensive clinical quality assurance program to optimize GCP compliance.
- Training employees in GCP guidelines and conducting simulated inspections to prepare the company for official audits.
- Optimization of clinical trial processes to ensure higher accuracy and quality of data.
Results.
- Successful GCP inspection without objections
- 15% increase in data quality in clinical trials through optimized testing processes.
- Improved preparation for inspections through thorough risk assessments and process optimization.
Success.
The company successfully passed the GCP inspections and optimized its clinical trial processes, resulting in higher quality clinical data.
Meet regulatory requirements efficiently.
Comprehensive pharma consulting services at a glance.
Get to know our experts.
Get in touch with our experts from the pharmaceutical industry.