Services
Consultant to the Pharmaceutical, Cosmetic, Agrochemical, Veterinary, Nutritional, Flavors and Fragrances and Fine Chemical industries in the following areas:
Active Pharmaceutical Ingredient Scale-up and Production:
- Critical independent expert review of an existing chemical process to identify problems which can save time and expense during the critical scale up and validation program.
- Process scale-up and support of GMP Production at the Kilo lab, pilot plant and production plant level.
- Development of Pharmaceutical Serialization procedures for cGMP materials prepared in the kilo lab and pilot plant; Harmonization of existing systems to avoid duplications of serialization codes from multiple facilities.
- CMC section preparation for IND and NDA submission.
- Technical writing.
- Interactions with Federal Agencies (FDA, NIH, BARDA and DEA).
- Raw material and synthetic intermediate sourcing, with expertise in domestic and offshore procurement.
- Market analysis of potential innovator, generic and veterinary drugs, medical devices, cosmetics, nutritionals, flavors and fragrances and fine chemicals.
- Identifying and qualifying third party API manufacturing facilities.
- Identifying and qualifying dosage form development and production facilities.
- Advise and manage the implementation of GMPs in cosmetic and nutritional manufacturing facilities.
