Kittiya Nopparatrungroj

Consultant, Regulatory Affairs

Biography

Kittiya Nopparatrungroj is a consultant in Tilleke & Gibbins’ regulatory affairs team in Bangkok and is a licensed pharmacist in Thailand. She advises and assists international and local clients in the pharmaceutical, medical device, and broader life sciences industries on market entry, obtaining and maintaining marketing authorization licenses, advertising and marketing regulations, and other related regulatory affairs matters. She also regularly prepares and reviews registration dossiers, and evaluates the feasibility of product registrations, advertisements, and labeling material for pharmaceutical products and medical devices.

Kittiya regularly authors articles covering updates of Thai laws and regulations applicable to the pharmaceutical and medical device industries. In addition, she has participated in several seminars and webinars on the same topics.

Kittiya graduated with a bachelor’s degree in Pharmaceutical Science from Mahidol University. During her studies, she completed internships with a local drug manufacturer and a local cosmetics manufacturer in Thailand. She also received a scholarship to intern at the Analytical Chemistry Institute of Johannes Kepler University in Austria, where she conducted research on steroid hormones from placenta extract.

Experience

  • Advised a client on obtaining a drug/medical device import license from the Thai FDA. Among other things, we assisted with office searches and renovation plans, and consulted with potential pharmacist candidates and license holders to ensure that the client met Thai FDA requirements to obtain license approval.
  • Assisted an international U.K.-based pharmaceutical company with Thai FDA product registrations and local manufacturing site certification following a significant acquisition of certain pharmaceutical and consumer health products from a major U.S.-based consumer healthcare manufacturer. Prior to this matter, Tilleke & Gibbins also advised the client on corporate establishment and the subsequent due diligence for the acquisition.
  • Invited to speak at multiple online seminars on the responses from the Thai FDA and the Department of Internal Trade to the COVID-19 outbreak. Notably, one of these sessions was conducted in collaboration with the Thai Listed Companies Association, and another was for the Licensing Executives Society, Thailand.
  • Provided comprehensive advice to clients in the life sciences industry on the classification of combination products, importation of drugs under the free-of-charge scheme, advertisement of healthcare packages on websites, permissible claims of medical devices and drugs, and the transfer of drug marketing authorization licenses.
  • Assisted various clients by preparing technical documents such as drug and medical device registration dossiers, Thai translations of drug package inserts, Good Manufacturing Practice (GMP) clearance dossiers, and variation dossiers, among others.
  • Assisted one of the world’s leading manufacturers of energy drinks on a number of Thai FDA matters.
ABOUT Kittiya

Industries

Life Sciences

Location

Languages

    Thai

    English

Insights

Awards & Rankings

Other Professionals

[show_printToPdf]