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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
+852 25760298
18/F Catic Plaza,
8 Causeway Road,
Causeway Bay,
Hong Kong
©2022 Leawell International Limited
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