CMC technical oversight
CMC technical oversight
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Creative, cost effective and rigorous oversight of CMC related activities to support IND enabling through to late stage clinical and commercial using our network of partners and Chemacopia advisors
Route selection and evaluation
Clinical and commercial supply planning
Vendor selection strategies
Manage tech transfer of chemical processes
Process validation
Implementing DOE and QBD
Design of studies to characterize PARs & NORs
Materials & production planning and control
CDMO identification, selection and technical and relationship management
Contract management and negotiation
Logistics and distribution management
Quality Agreements and Quality risk assessment
Vendor audits
Gap analysis for regulatory submissions and support for IND, IMPD, NDA and PAS filings
Technical report writing and reviewing
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