From complex regulatory affairs to dynamic CMC submission, SommaTech regulatory experts rapidly identify development, manufacturing or stability issues that could impact product registration.
Regulatory, Quality Assurance and CMC Support
- Due Diligence for Products, Compounds, Process, and Supply Chain
- CRO/CMO Selection
- Quality Risk Analysis for Products and Processes
- Novel Product Engineering Merged with Regulatory Strategy
- Expert Advice From Submission through Pre-Approval Inspection
