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Stem - Make The Future With Heart

Registration Affairs

Detailed

STEM Registration Department is well familiar with regulations of ICH and Chinese regulatory authorities, with deep understanding and interpreting changes of regulations and technical guideline principles of CDE, CDR and other relevant reviewing departments, we can accurately grasp registration and specific requirements of application documents, and providing précised services of products’ regulatory consultation and registration for our clients.

We have enriched experience in accurately evaluating and analyzing projects, preparing and organizing various CDE communication meetings, towards submitting final application documents to CDE to get approvals.

The service scopes of products include import/domestic drugs, medical devices, pharmaceutical excipients, and pharmaceutical packaging materials etc.

  • Registration services include:

    Consultation on pharmaceutical laws and regulations;

    Declaration strategy formulation;

    Writing the application materials;

    Declaration process tracking.

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