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Regulatory Affairs and Strategy




    Our Services:

  • Drug registration in China - CTA, MRCT, NDA, BLA and other supplement or variation
  • Drug registration in US – IND, NDA, BLA, ANDA and other variation
  • CDE and US FDA consultation and panel meetings including Pre-IND / End of Phase I or II meeting / Pre-NDA meeting
  • Submission strategy consultation, plan and risk assessment
  • Quality control and management for dossier – CTD, eCTD, NeES
  • SOP Development
  • Consultation

  • Our Experience and Capabilities:

  • A group of highly qualified professionals with more than 10 years of drug registration and management experience from leading multinational pharmaceutical and CRO companies in both US and China
  • Team members specialized in medicine and biochemistry with master and advanced degrees from US, Canada and China
  • Professional experience covering regulation interpretation, drug registration, dossier quality control, and project management for drug registration
  • Extensive experience working in broad spectrum of different areas including CMC, nonclinical, pharmacology, toxicology, and clinical development
  • Thorough knowledge of ICH, regulations in China and US, as well as that in Asia Pacific countries

China:
298 Xiangke Road, 3/F, 301-305, Pudong New District, Shanghai 201210
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515

United States:
3800 Paramount Pkwy, Suite 100 Morrisville, NC 27560
Tel: +1 919-224-8800

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