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RA department is consistedby a group of professionals with various professional academic background andyears of experience, including R&D, QA, QC,production and regulatory affairs. RA department includes Internationalregistration division and Domestic registration division.

International registration division, responsible for registration ofexport products, including API, formulation, cosmetic ingredients and plant extracts

1. Ensure that products comply with the latest regulations.
2. Strictly follow up the registration procedure,from dossier preparation, on-site inspection to deficiencycorrection.
3. Cooperate with Imp. & Exp. Dept. andprepare documents required for Formulation’s import & export.
4. Participate in preparing five EDMFs with CTD format, two of which have been submitted in regulated markets.


Domestic registration division, responsible for registration of import products, including formulation, cosmetics and health food.

Ø  Conducting a clear and comprehensive market research to help our partner select products to launch in China

Ø  Sign CDA, keep our partners’ technical information in strict confidential. Translateall product dossiers into Chinese, and ensure the product dossier conform tocurrently published Chinese laws and regulations

Ø  Followup with CFDA, CDE and NIFDC closely in person regarding the registration status

Ø  Customs clearance for the product samples required by NIFDC for sample test. And keepon tracking the status of sample test, to make sure the products meet all therequirements of NIFDC.

Ø  Help our partner perform BE study or clinical trials (if necessary) in China.

Ø  Promote the products with our long-term esteemed Chinese pharmaceutical companies anddistributors.

 
 
 
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