Committed to strengthening your innovations and development
All companies, from small life science startups to established biopharma companies, need to develop the most efficient CMC strategies and find the right competence for their current phase of development. With long experience and an agile mindset we provide tailored CMC solutions in each phase of the drug development cycle. We are also a trusted partner to provide assessments of projects and companies prior to investments, and regularly contribute through investments of our own.
Our areas of expertise include:
Expert advice on CMC strategies
Our advisory meetings may result in GAP-analysis, a strategic roadmap or other solutions that will help our clients make the right decisions at the right time. We support our clients to take future demands into account, thereby reducing the risk of costly mistakes.
We support our clients to define the project objectives and selection criteria to find suitable vendors. We evaluate, benchmark and select the best match.
With our knowledge and insights into the CMC processes and established legal network we help clients negotiate contracts achieving better outcomes as well as saving time and costs.
We provide services such as project management to ensure a smooth and effective technology transfer of drug substance manufacturing.
CMC Project Management
With an agile mindset to CMC Project Management we have long experience in delivering tailored solutions to meet the specific needs of each company we support. It may involve full management responsibility long term or short term, or support with specific tasks.
We have long experience and an in-depth understanding of manufacture and testing of biologics according to applicable GMP requirements, and provide a wide range of services within Quality Assurance.
Process Performance Qualification, PPQ
As a part of our Quality Assurance services we help you design your PPQ, a vital component to late drug development required by regulatory authorities to ensure reproducible product quality over time.
Our knowledge and experience in the field of CMC has made us a trusted partner to provide due diligence assessments of both products/projects and companies prior to investments or acquisitions and in contract negotiations.