ABOUT US

Yan Hai

President, Innova Medipharm Inc.​

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Yan Hai is a senior GxP and quality compliance professional with an M.A.Sc. in Biomedical and Chemical Engineering and more than 20 years of experience across the life sciences industry. She serves as a senior QA consultant and fractional senior QA leader, bringing experience from both industry and consulting roles, along with a strong foundation in scientific research, analytical and bioanalytical testing, and quality control. This diverse background enables her to effectively bridge scientific development, CMC, and quality functions with practical, scalable, and compliant quality systems.

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Yan Hai has deep expertise in cGxPs, quality systems, analytical and bioanalytical oversight, and global regulatory compliance, with extensive experience working within FDA, Health Canada, EU, and MHRA regulatory frameworks. As a fractional senior QA leader and trusted advisor, she supports organizations from early development through commercialization by interpreting evolving regulatory expectations, implementing phase-appropriate quality systems, identifying and closing compliance gaps, conducting GxP audits, leading risk-based assessments, and strengthening inspection readiness. She has supported more than 300 projects, helping companies build robust quality infrastructures and advance development efficiently and confidently.

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​Selected Clients:

• Sanofi Pasteur

• Daiichi Sankyo

• Alcon Canada

• Thermo Fisher Scientific

• Eisai Limited

• Karyopharm Therapeutics

• Scholar Rock

• Ocugen

• Savara

• Baylor Scott & White Research Institute

• Secura Bio

• Taro Pharmaceuticals

• Septodont

• Vivo Cannabis

 

Education:

Master of Applied Science, University of Toronto, Canada                                           

Majors: Chemical Engineering and Applied Chemistry & Biomaterials and Biomedical Engineering

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