Regulatory Affairs

Our regulatory experts have years of experiences with the FDA, NMPA, and the EU health authorities and are familiar with differences in local regulatory requirements. They can provide you with feasible strategies and act as liaison with various regulatory agencies, both on technical and regulatory issues.

Thanks to our Chinese origin, we have successfully supported hundreds of companies to enter the Chinese market.

Key activities:

  • Act as liaison

  • Dossier preparation, writing, submission

  • Dossier review

  • Maintenance

  • Feasibility assessment

  • RA / CMC

  • Clinical RA

  • Medical translations