Drug Product Development
Drug development begins with the synthesis of a molecule, making active pharmaceutical ingredient (API) production a critical element to any drug development program. Aptuit Consulting’s comprehensive drug development expertise encompasses development and manufacturing services to support all phases of CMC for a product from discovery through to commercialization.
Aptuit Consulting’s CMC-services include:
- Formulation Development from pre-clinical to commercial
- Drug Substance
- Drug Product
- Stability Program Design
- Impurities risk assessment strategy (including genotoxic impurities)