You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

Kunanon Sereesawetrat

Consultant, Regulatory Affairs

Biography

Kunanon Sereesawetrat is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok, where he assists clients with matters related to medicinal products, medical devices, and healthcare-related innovations. He has extensive experience in product registration with the Thai Food and Drug Administration and advises clients about Good Manufacturing Practice (GMP) guidelines, Good Storage and Distribution Practices (GSDP), and Good Clinical Practice (GCP) guidelines for clinical trials. He also assists clients with maintaining and amending marketing authorizations throughout the lifecycle of their products, and he advises on current life sciences regulations, especially in relation to pharmaceuticals and medical devices, based on local and overseas regulations (e.g., EMA and USFDA).

Prior to joining Tilleke & Gibbins, Kunanon was a regulatory affairs executive for multiple pharmaceutical companies in Thailand, where he was responsible for supervising GSDP and handled the registration of medicinal products, including generics and biosimilars.

He is also an active member of the Thai Industrial Pharmacist Association (TIPA), the Regulatory Affairs Pharmacy Association of Thailand (RAPAT) and the Pharmaceutical Association of Thailand under Royal Patronage. His frequent participation in regulatory update meetings held by regulatory authorities, RAPAT, and TIPA provides valuable opportunities for Kunanon to convey the concerns and interests of his clients in key industry venues.

Kunanon holds a bachelor’s degree (Doctor of Pharmacy, PharmD) from Mahidol University and a license to practice the pharmacy profession from the Pharmacy Council of Thailand.

Experience

  • Prepared applications and reviewed related documents for product approval licenses for registration and variation of drugs and medical devices in compliance with FDA regulations.
  • Assisted local and international pharmaceutical companies in publishing services (both full ICH eCTD and NeeS) to obtain the document packages used for medicinal products (both chemical and biologics) registration and variation, in compliance with FDA requirements and regulations.
  • Provided comprehensive advice to a contract research organization (CRO) and company that were sponsors upholding clinical trial requirements on their responsibilities and potential penalties for noncompliance in Thailand.
  • Provided advice to a local company on the relevant legal requirements for importation of advanced technology-derived biological products and advanced therapy medicinal products (ATMPs) into Thailand.
  • Advised various local and international pharmaceutical and medical device companies on strategies for obtaining import licenses, manufacturing licenses, product registration, product variation, and other related submissions necessary for complying with the Thai FDA regulatory framework.
  • Advised an international company with different business lines on obtaining a product license and import licenses for connected agricultural technology.
ABOUT Kunanon

業務分野

規制法対応

拠点

Languages

    Thai

    English

Education

    PharmD, Mahidol University

情報

Awards & Rankings

Other Professionals