Industries.
Life Sciences Consulting.
Expert.
Efficient.
Holistic.
Optimize your processes and meet all requirements.
Life Sciences Consulting - Holistic consulting for your industry.
Our Life Sciences Consulting solutions offer comprehensive support that is tailored precisely to your needs.
Our Life Sciences Consulting offers customized consulting approaches that help you achieve short-term goals as well as develop long-term strategies. Our expertise spans the areas of Project Consulting, Hybrid Consulting and Strategy Consulting, with a particular focus on the specific requirements of the pharmaceutical, biotech, medical technology and IVD sectors.
From strategic planning to operational implementation, we work closely with you to optimize your processes, increase efficiency and ensure that you meet all regulatory requirements. We support you at every stage to ensure your projects are completed successfully and your business can grow sustainably.
With Entourage as your partner, you benefit from our in-depth industry knowledge, which enables you to remain competitive and successful in a dynamic and regulated market environment.
Our sectors in Life Sciences Consulting.
Medical technology.
- MS&T: Optimization of manufacturing processes according to GxP standards.
- Quality Management: Implementation and improvement of quality assurance processes.
- Clinical, Medical & PV: Support for clinical trials and pharmacovigilance.
- Regulatory advice: Advice on compliance with regulatory requirements.
- GxP compliance: Ensuring compliance for all pharmaceutical processes.
IVD.
- IVDR certification: Consulting and implementation of processes for certification according to IVDR standards.
- Quality management: Introduction and optimization of quality management systems for IVD products.
- Product development: Support in the development of new diagnostic products.
- Quality control: Ensuring product quality and carrying out checks.
- Research & Development: Support in the R&D of IVD products.
Pharma.
- MS&T: Optimization of manufacturing processes according to GxP standards.
- Quality Management: Implementation and improvement of quality assurance processes.
- Clinical, Medical & PV: Support for clinical trials and pharmacovigilance.
- Regulatory advice: Advice on compliance with regulatory requirements.
- GxP compliance: Ensuring compliance for all pharmaceutical processes.
Biotech.
- Specialized consulting for the in-vitro diagnostics industry.
- Process optimization: Improvement and automation of production processes.
- Technology transfer: Support for the transfer of new technologies into the production process.
- Market entry: Strategies for entering new markets and expansion.
- Scaling: Optimization of production capacities for growing requirements.
Ensure efficiency and compliance with Life Sciences Consulting!
Discover our sectors in Life Science.
Case Studies - Successful consulting projects in all life science sectors.
Challenge.
A leading pharmaceutical company had to bring a new drug to market under strict time pressure and with limited resources. Internal processes were inefficient and compliance with strict regulatory requirements was a major challenge.Measures.
- Introduction of an agile project management approach to improve flexibility in the development phases.
- Support in the preparation and submission of regulatory documentation in accordance with EMA and FDA requirements.
- Work closely with internal teams to optimize coordination between departments.
- Conduct training for the team to ensure compliance with GxP regulations.
Results.
- The drug was launched on time and received approval in both the EU and the USA.
- The efficiency of internal processes was increased by 25 %.
- Internal communication and cooperation between departments improved significantly.
Success.
The successful market launch of the drug led to a 35% increase in sales. Agile project management was extended to other projects in order to sustainably improve efficiency.Challenge.
A medical technology company was about to introduce new production methods that had to comply with ISO 13485 and IEC standards. The challenge was to implement the new technology without interrupting production.
Measures.
- Development of a strategic roadmap for implementing the new technology.
- Integration of agile methods for flexible adaptation to new challenges during the implementation process.
- Conducting training to ensure compliance with ISO 13485 standards and to ensure quality management.
- Implementation of a continuous quality monitoring system.
Results.
- The new technology was successfully introduced without interrupting ongoing operations.
- Production costs were reduced by 18% and production capacity increased by 30%.
- The ISO 13485 requirements were met in full and product quality improved sustainably.
Success.
Thanks to the optimized production capacity, the company achieved increased competitiveness and was able to expand into new markets.
Challenge.
A biotechnology company planned to expand into three international markets but lacked a clear market entry strategy. There were challenges in complying with local regulatory requirements and identifying potential partners.Measures.
- Carrying out a comprehensive market analysis to identify entry barriers and potential market segments.
- Development of a customized market entry strategy for each market.
- Support in implementing the strategy through training and cooperation with local partners.
- Ensuring compliance with regulatory requirements in each market.
Results.
- Successful entry into the three new markets and establishment of long-term partnerships.
- Increase in sales in the new markets by 28 % in the first year.
- Long-term market positioning and successful launch of new products.
Success.
Thanks to its successful market entry, the company was able to significantly expand its international presence and tap into additional growth opportunities.Challenge.
An IVD company was planning to develop a new diagnostic product that had to meet the requirements of the IVDR. The company was faced with the challenge of meeting the regulatory requirements and at the same time speeding up the market launch.Measures.
- Carrying out a detailed IVDR analysis to identify the regulatory requirements.
- Support in the implementation of a quality management system that complies with IVDR requirements.
- Support in the development of the diagnostic product, including the optimization of production processes and product certification.
- Coordination with the regulatory authorities to speed up approval
Results.
- The diagnostic product received IVDR approval within the planned timeframe.
- Internal processes have been optimized so that future products can be brought to market faster.
- The company met all regulatory requirements and was able to strengthen its position on the market.
Success.
Thanks to the successful market launch and compliance with IVDR requirements, the company was able to significantly increase its sales and create a solid basis for future products.Advance your life science projects!
Discover our life sciences solutions.
Hybrid Consulting.
Our hybrid consultancy combines in-depth analysis and solutions with the efficiency of operational excellence.
Project Consulting.
Find the right project consulting expert for your pharmaceutical and medical technology project now.
Strategy Consulting.
Our customised life sciences consulting makes you fit for future challenges.