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Regulatory Advisory

APIs & FDFs Registration in China

-  We propose optimized and customized registration strategies based on comprehensive review of technical information
-  We increase the chances of success with our updated knowledge in the latest expectations of the regulatory authorities  

-  We translate and compile your dossiers according to the relevant requirements

-  We keep your information confidential

-  We coordinate with the relevant authorities to resolve the deficiencies 

Leawell's Approach 


Market Research & Survey

Project Agreement between the parties

Provide professional and elaborate data gap analysis

 Provide customized dossier analysis and optimized registration strategy

Translation, compilation and

   submission of dossiers

Quality evaluation and verification by NIFDC

Technical Review by CDE

Assist in Clinical Trial, if necessary 

Deficiency Letter

-  Proactively coordinate with different parties to resolve the deficiencies

Registration Complete

Have any questions? Leave a message below!

+852 25760298

18/F Catic Plaza,
8 Causeway Road,
Causeway Bay,
Hong Kong

©2022 Leawell International Limited

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