CMC & Regulatory
Chemistry, Manufacturing and Control (CMC)
- cGMP manufacturing of active pharmaceutical ingredients
- Reference standard certification
- Impurity and metabolite identification and characterization
- Stability study
- Analytical method development and validation
- Regulatory document preparation and submission
- Strategic planning of CMC for IND and NDA
Preclinical, Clinical and Regulatory Management
- Assessment of ADMET properties for lead optimization and drug candidate selection
- Design and management of IND-directed preclinical (in vitro and in vivo) studies
- Regulatory planning, design and management of Phase I clinical trials
- Regulatory document preparation and submission
- Management of regulatory communications with the FDA and other agencies