top of page
Regulatory Compliance
Our regulatory experts identify, development, commercial manufacturing or stability issues that may affect product registration. Some of our Regulatory, Quality Assurance and CMC Support services include:
-
Due Diligence for Products, Process, and Supply Chain
-
FDA Meetings
-
FDA Submissions
-
Quality Risk Analysis for Products and Processes
-
Novel Product Engineering combined with Regulatory Strategy
-
Expert Advice on Product Submission through Pre-Approval Inspection
-
CMC support eCTD preparation and submission support
bottom of page