Kate Zhou-KRB CONSULTING | Beijing KRB

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Name: Kate Zhou

Position: Partner/Deputy General Manager

Kate Zhou

Partner/Deputy General Manager

Background:

• Drug registration expert, 17+ years experiences for drug R&D and regulatory affairs

• Undertake or guide 30+ NDA and ANDA

• Support 10 enterprises obtain MA in EU for generics

• Support 10 enterprises apply for IND/NDA/ANDA in the US

• Support 20 enterprises obtain IDL (imported drug license), approval of Phase I/III for chemical drugs (category 1) and approval of Phase I for domestic biosimilar

• 70+ projects, including CEP for chemical API, herbal, fermentation API, FDA API and packaging material DMF filing

• Presented as Speaker at NMPAIED and other Institutes

Good at:

• Strategies and planning for Innovative and generic drug’s submission in China

• Radioactive pharmaceuticals and psychotropic drugs submission

• Generics submission in FDA and EU

CONTACT

Phone number：400-0123-669

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

https://www.kingrabroad.com/

E-mail：info@kingrabroad.com

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