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Chemical process R&D for small-molecule and peptide APIs
Support on process development, optimization, and scale-up
Non-GMP and GMP manufacturing support with preferred CDMO partners
Guidance on analytical method development and physicochemical characterization
CMC strategy development and coordination
RFP preparation, supplier evaluation, and ongoing supplier management
Authoring and review of technical development reports and regulatory CMC documentation (IND/NDA)
Drug substance optimization through salt selection and polymorph screening
Peptide synthesis optimization, including upstream/downstream processing, resin selection, protecting-group strategies, and impurity control
Chemical process R&D for small-molecule and peptide APIs
Support on process development, optimization, and scale-up
Non-GMP and GMP manufacturing support with preferred CDMO partners
Guidance on analytical method development and physicochemical characterization
CMC strategy development and coordination
RFP preparation, supplier evaluation, and ongoing supplier management
Authoring and review of technical development reports and regulatory CMC documentation (IND/NDA)
Drug substance optimization through salt selection and polymorph screening
Peptide synthesis optimization, including upstream/downstream processing, resin selection, protecting-group strategies, and impurity control