CMC
Strategy and Compliance
We develop CMC strategies through our extensive experience in development
and international CMC Regulations, as well as advice on the application of
cGMPs to an R&D environment:
CMC
Strategy
- Design
of CMC Development Plans
- Interpretation
of CMC Regulations
- Project
Management and Review
- Writing
and Review of Regulatory Submissions
Compliance
- Integrated
Quality Systems
- SOPs,
Guidelines, Best Practices, Training Manuals and Training Programs
- Writing
and Review of Technical Reports
