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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

September 9, 2026
On August 5, 2026, the Consumer Case Division of Thailand’s Civil Court rendered a judgment in a case involving a beauty clinic that advertised acne scar treatments using claims that the clinic was operated by a specialist physician and that the treatment, allegedly involving stem cell technology, could permanently remove acne scars. The plaintiff brought a claim against both the physician-owner and the clinic company, alleging that the advertisements were false and induced her to purchase the treatment. The court found that the clinic was liable for the false representations and that the physician-owner, as both the authorized director of the company and the medical practitioner who provided treatment, was jointly responsible. Although the plaintiff could not fully prove all damages claimed, the court awarded compensation of THB 20,000, together with interest. While the judgment arose from a consumer protection dispute, it serves as a valuable reminder that medical facility advertisements in Thailand are regulated and may expose clinics and healthcare providers not only to regulatory enforcement but also to civil liability from patients who rely on misleading promotional claims. Regulatory Framework Governing Medical Facility Advertisements Medical facility advertising in Thailand is governed by the Medical Facility Act B.E. 2541 (1998), as amended by the Medical Facility Act (No. 4) B.E. 2559 (2016). The principal secondary legislation is the Department of Health Service Support (DoHSS) Notification Re: Rules, Procedures, Conditions, and Fees for an Advertisement or Publication Concerning a Medical Facility, which came into force on November 25, 2019. Under this notification, “advertising” includes any act, by any means, that causes members of the public to see, hear, or otherwise become aware of a message, sound, or image for the commercial benefit of a medical facility. This broad definition covers not only traditional media but also clinic websites, social
August 20, 2026
As part of its membership in Lex Mundi, Tilleke & Gibbins has released the latest edition of its Guide to Doing Business in Thailand, providing an overview of the legal, regulatory, and commercial considerations for companies establishing or expanding operations in Thailand. The 2026 edition offers practical insight into the country’s business environment, investment framework, and operational requirements. The guide covers a wide range of topics relevant to foreign and domestic investors, including: Investment incentives and promotion schemes Financial facilities and banking regulations Exchange controls and money transfers Import and export regulations Business structures and incorporation options Requirements for establishing a business Operational and compliance considerations Business cessation and insolvency procedures Employment and labor laws Taxation Immigration and visa requirements Prepared by Tilleke & Gibbins lawyers across multiple practice areas, the publication outlines key aspects of doing business in Thailand, including foreign investment restrictions, regulatory compliance obligations, corporate structures, employment requirements, and recent legal and economic developments affecting investors. The publication forms part of Lex Mundi’s Country Guides series, a global collection of jurisdiction-specific reference materials prepared by member firms around the world. Together, these guides help companies evaluate opportunities, compare regulatory environments, and plan international business activities across multiple markets. The full Guide to Doing Business in Thailand 2026 is available through the button below.
July 1, 2026
Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.
May 2, 2025
Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.

Awards & Rankings

April 3, 2026
Tilleke & Gibbins is pleased to announce that the firm has been shortlisted in two categories at the Financial Times (FT) Innovative Lawyers APAC 2026 awards: Innovative Lawyers in Cyber and Data Privacy – “Digital Identity & Cryptocurrency Compliance” Innovative Practitioner – Athistha (Nop) Chitranukroh The FT Innovative Lawyers APAC Awards recognize law firms and practitioners who are driving innovation in legal services and delivering innovative client solutions across the Asia-Pacific region. This recognition marks our third acknowledgment in the Innovative Lawyers category and, notably, our first-ever nomination in the Innovative Practitioner category at the FT Innovative Lawyers APAC awards. It reflects our team’s continued ability to support clients on groundbreaking, forward-looking projects across the region. The awards ceremony will take place on May 14, 2026, in Hong Kong. To learn more about the FT Innovative Lawyers APAC 2026 awards and to view the full list of shortlisted organizations, please visit the FT website.
March 19, 2026
Tilleke & Gibbins has been recognized in 17 categories at the 2026 Thailand Law Firm Awards from Asia Business Law Journal (ABLJ), up from 10 categories in 2025. The awards highlight leading law firms in Thailand across a broad range of practice areas, as well as overall firm performance. This year, Tilleke & Gibbins was named a co-winner in the Best Overall Law Firm category as well as in the following practice-specific categories: Artificial Intelligence Aviation Blockchain & Digital Assets Competition & Antitrust Data Compliance & Cyber Security E-Commerce, Digital Trade & Platform Regulation ESG (Environmental, Social, and Governance) Fintech Healthcare & Life Sciences Insurance & Reinsurance IP Litigation IP Prosecution Labour & Employment Private Equity & Venture Capital Shipping & Maritime Technology, Media & Telecommunications The awards are determined through ABLJ’s independent research, which considers recent work, client feedback, and market standing. The annual Thailand Law Firm Awards recognize firms demonstrating strong performance and breadth of expertise across key practice areas. For more details and the full list of winners, please visit the ABLJ website.
March 9, 2026
Tilleke & Gibbins has been shortlisted in multiple firmwide and individual categories at the Legal 500 Southeast Asia Awards 2026, including Regional Firm of the Year, reflecting the firm’s work across Southeast Asia and the continued development of its regional practices. In the individual categories, Aye Thuzar Hlaing has been shortlisted for Myanmar Associate of the Year (Corporate and M&A), and Linh Duy Mai has been shortlisted for Vietnam Associate of the Year (Intellectual Property). Tilleke & Gibbins has also been shortlisted in the following firm categories: Regional Firm of the Year Thailand – Law Firm of the Year Thailand – Law Firm of the Year (Litigation) Myanmar – Law Firm of the Year Vietnam – Law Firm of the Year Vietnam – Law Firm of the Year (Labor and Employment) Laos – Law Firm of the Year The winners will be announced on April 30, 2026, at the Legal 500 Southeast Asia Awards ceremony in Singapore. To browse the full shortlist for the Legal 500 Southeast Asia Awards 2026, please see the Legal 500 website.

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