OUR COMPANY

Name: Celein Shen
Position: Partner/RA Associate Director

Celein Shen

Partner/RA Associate Director

Background:

14 years experiences of drug R& D and regulatory affairs

Expertise in China, FDA and EU regulatory market for API and FDF registration

20+ FDF projects

50+ DMF projects for API, excipients and packaging

Good at:

• Generics MAA in FDA and EU

• MAA in China

• API filing in China and CEP application to EDQM

• CMC R&D guidance

• Radioactive pharmaceuticals submission

CONTACT

Phone number

Phone number:400-0123-669

Address

Address:A805, Tower A, Chaowai SOHO, 6B Chaowai Street, Chaoyang District, Beijing 100020

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