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CMC - Small molecules

Comprehensive, integrated CMC services for small molecules

With expertise in chemistry, pre-formulation and pharmaceutical development our CMC experts provide solutions to the challenges of each of these disciplines.

Expertise

Our consultants and advisors cover all phases of development and are adept at designing and delivering CMC packages for small molecules, from candidate selection to proof-of concept, that meet client timelines and budgets. Our knowledge of technical,regulatoryand cGMP requirements results in the most streamlined approach to each project.

Complexities at the interfaces between CMC, preclinical andclinical developmentoften give rise to unnecessary delays in projects. Ourpreclinicalandearly phaseexperts work collaboratively with clients to provide an independent and objective analysis to help them transition seamlessly between each discipline and ensure that lead candidates move smoothly through development and project milestones. The small molecule CMC team is experienced in:

Development strategy for small molecules

  • 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 labeling
  • Quality Control
  • Stability testing
  • Change management
  • Trouble shooting
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