Regulatory Affairs

Asymchem’s pharmaceutical administration team has global application experience to provide global customers with small molecule chemical drugs, chemical macromolecule drugs, IND of biological drugs, NDA / BLA, supplementary applications and other CTD data (CMC research section, clinical trials) bilingual writing and registration services. The core members of the registration team have more than ten years of drug registration experience and rich project management experience; the team members have multi-module expertise and follow-up the whole process from the initial development of the drug, the overall CMC, to clinical research, etc. to ensure that the data meets various regulatory agencies requirements. The team is experienced working or government communication channels and understand regulatory guidelines and review requirements, and speed up drug registration approval. The main receiving agencies include FDA, EMA, TGA, NMPA.


Legal support

● CMC, clinical registration research & development plan;

● Global and China registration strategy evaluation;

● Registration strategies / channels for various meetings and communications with official agencies;

● Interpretation of regulations;

● Point-to-point consultation

Registration service

● Institutional meetings, including type 1,2,3 CDE consultation meetings and other meeting

(Including submitting meeting requests, preparing meeting documents and attending meetings to assist clients in communicating with regulatory agencies); 

● Gap analysis of CMC, non-clinical and clinical parts of the archives in accordance with relevant regulations and guidelines;

● IND / CTA application, NDA / BLA application; annual report and supplementary application;

● Update and change of production license

● Monitor and follow up on review progress

   (Including responses to any oral / formal questions and deficiency letters with the consent of the client)

Report and application dossiers writing service

● Writing of IND, NDA and ANDA declaration materials ( including M2, M3, M5, sections CTD documents)

Compilation of supplementary applications dossiers of related annual report .

On-site inspection

● Preparation of inspection documents

● Assisting on-site inspection and unannounced inspection

Postal Address
  • Asymchem Inc. 600 Airport Blvd PO Box 1310
  • Morrisville NC 27560 USA
Physical Address
  • Asymchem Inc.
  • 600 Airport Blvd., Suite 1000 Morrisville, NC 27560 USA
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