Examples of experience
- Oversight of Drug Substance process qualification and validation at an European CDMO
- Requests For Proposals to US Drug Product manufacturers with lyophilization and aseptic manufacturing expertise
- Selection of the US-based CDMO in view of its technical experience, quality, costs and capacity
- Negotiation of the Clinical Supply Agreement and Technical Quality Agreement
- Transfer of the Drug Product manufacturing process from the European CDMO to the US and review of manufacturing records
- Definition of the CMC regulatory strategy in view of IND filing at the US FDA and drafting of the Module 3 CMC components
- Set-up of the development strategy for the drug product and medical device
- List of questions for regulatory agencies
- Review of Briefing Document and attendance to Scientific Advice at MHRA
- Oversight of the transfer of a complex manufacturing process from the lab to cGMP manufacturing and terminal sterilization at external partners
- Risks assessment and mitigation plans
- Review of Complete Response Letter issued by the FDA and strategy for responses
- Regulatory assessment and compliance check in relation to the implementation of the Drug Substance analytical methods at the Drug Product manufacturing site
- Guidance about the analytical program and acceptance criteria for impurities
- Establishment of an action plan to demonstrate the discriminating ability of the selected dissolution method
- Input in the definition of the Target Product Profile of a sterile depot formulation for treatment of rheumatoid arthritis
- Draft of the CMC development program with associated costs and timelines
- Risks assessment and major de-risking plans
- Presentation of the CMC program to Drug Associations and Venture Capitals to raise funds and grants
- Advice on technology selection based on physicochemical and biological properties of the API
- RFPs and selection of partners for API and Drug Product manufacturing, analytical and clinical services
- Coordination and oversight of deliverables at CDMOs
- 30 weeks from API and Drug Product manufacturing till IND package ready for FDA submission
- Team work to establish the Quality Target Product Profile, Critical Quality Attributes and acceptance limits
- Guidance and scientific insight on Critical Material Attributes and Critical Process Parameters
- Extensive assessment of risks and mitigation plans
- Review of manufacturing protocols and reports