Post-market compliance and Legal Agent
BioHan Consulting can act as your local regulatory agent per your authorization, and help to ensure your post-market compliance. The responsibilities of the agent include:
-
Routine connection with NMPA and liaising between your company and NMPA
-
Help with adverse event reporting or recall activity if it happens, and Annual Risk Evaluation Report and Manufacure QMS Self-Inspection Report as NMPA required
-
Implementation or upgrading your systems to compliance with NMPA GMP and maintaining manufacturer’s license
-
Assistance with post-market facility inspections including internal pre-audit and attendance at external audit, as well as vendor/supplier audits