CMC Regulatory Support
We transform analytical data into submission-ready documentation for global regulators
Benefit
- Smooth integration of results into CMC packages
- Reduced risk of regulatory deficiencies
- End-to-end analytical and regulatory support
Techniques & Methods
Preparation of analytical sections
Module 3 / IMPD / IND / BLA / MAA
Interpretation of data with statistical validation
Gap analysis to identify missing studies before submission
Alignment with ICH
Q6B/Q8/Q14 for biologics