We use our long experience in the Pharmaceutical Industry to assure that work is done professional and cost effective. We offer the following expertise to ensure required quality and regulatory standards of your product:
- Development of smooth CMC and manufacturing strategies that meet regulatory expectations and fits to the overall development strategy
- Project management and management of third part providers
- Generating the CMC part of the regulatory package e.g. IMPDs, INDs and other regulatory documents
- CMC due diligence support