CMC Development – Small Molecules
The Aptiv Solutions CMC team, with staff located in the U.S. and EU, provides a comprehensive, integrated CMC service with a global perspective. With exper-tise in chemistry, pre-formulation and pharmaceutical development our CMC experts provide solutions to the challenges of each of these disciplines. We cover all phases of development and are particularly adept at designing and delivering CMC packages from candidate selection through to Proof-of-Concept that meet client timelines and budgets. Our contemporary knowledge of technical, regulatory and cGMP requirements results in the most streamlined approach to each project.
Complexities at the interfaces between CMC, Nonclinical and Clinical Development often give rise to unnecessary delays in projects. Our EPPS experts work collaboratively with clients to provide an independent and objective analysis to help them transition seamlessly between each discipline thus ensuring lead candidates move smoothly through development and project milestones.
The small molecule CMC team is experienced in:
Development Strategy
- Designed in partnership with the client
- Integrated with other functions
- Pragmatic solutions
- Managed through supplier net-work
- Regulatory CMC strategy (CTA/IND to MAA/NDA)
- Technology transfer
- Due diligence (in/out licensing)
API Development
- Route development
- Analytical development
- Manufacturing
- Quality Control
- Stability testing
- Change management
- Trouble shooting
Pre-formulation
- Candidate selection
- Polymorphism studies
- Salt selection studies
- Co-crystal evaluation
- Formulations for pre-clinical studies
Drug Product Development
- Clinical dosage form development
- Analytical development
- Manufacture of clinical trials material
- Clinical packaging and labelling
- Quality Control
- Stability testing
- Change management
- Trouble shooting
