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Suthinee Ongsakul

Consultant, Regulatory Affairs

Biography

Suthinee Ongsakul is a consultant on Tilleke & Gibbins’ regulatory affairs team in Bangkok. She assists clients with preparing healthcare product dossiers for registration of life sciences products, such as pharmaceuticals, medical devices, and herbal products. Suthinee also advises on regulatory affairs issues related to the life sciences industry.

Prior to joining the firm, she completed several internships relevant to the role, including positions at the Thai Food and Drug Administration, multiple pharmaceutical companies, and a multinational health technology and clinical research company.

Suthinee holds a Doctor of Pharmacy in Industrial Pharmacy from Chulalongkorn University and is a licensed pharmacist.

Experience

  • Provided regulatory guidance on the issuance of certificates of pharmaceutical products (CPPs) in accordance with Thai FDA requirements.
  • Advised on overseas GMP clearance processes for vaccines intended for the Thai market.
  • Reviewed and screened over 100 medicinal product registration renewal applications for submission to the Thai FDA.
  • Assisted in the preparation and submission of regulatory variations for biologic products.
  • Conducted literature reviews to support the development of a cost-effectiveness analysis on immunotherapy.
ABOUT Suthinee

Industries

Life Sciences

Location

Languages

    Thai

    English

Education

    PharmD, Chulalongkorn University

Insights

Awards & Rankings

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