- Chemistry, Manufacturing and Controls (CMC) section development for IND, NDA, and BLA
- Product formulation studies
- Process development for Active Pharmaceutical Ingredient (API) and final dosage forms, including:
- Peptides
- Nucleotides
- Small molecules
- Drug / device combination products
- Vial, cartridge, and pre-filled syringe final product presentations
- Aseptically processed and terminally sterilized injectable dosage forms
- Liquid, lyophilized and dry-powder fill/finish
- Solid dosage final product presentations
- Contract manufacturer identification and management
- Cost of goods analysis
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