Post-market compliance and Regulatory 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:
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Routine connection with CFDA and liaising between your company and CFDA
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Help with adverse event reporting or recall activity if it happens, and annual summary report as CFDA required
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Implementation or upgrading your systems to compliance with CFDA GMP and maintaining manufacturer’s license
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Assistance with post-market facility inspections including internal pre-audit and attendance at external audit, as well as vendor/supplier audits