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Life Sciences

Life Sciences

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

OVERVIEW

Our unified teams of legal and scientific professionals across Southeast Asia offer unparalleled expertise in the life sciences.

The Tilleke & Gibbins life sciences team combines experienced commercial attorneys, patent experts with technical degrees, and licensed pharmacists with industry experience to offer a full range of services to companies operating in pharmaceuticals, cosmetics, food and beverages, biotechnology, medical devices, veterinary products, consumer products, and other life sciences sectors. We stand ready to assist you with:

  • Regulatory Affairs.   Registration and prosecution of pharmaceuticals, biotech products, food and food supplements, narcotic and psychotropic substances, medical devices, cosmetics, hazardous substances, and animal and crop health products with national food and drug agencies and agricultural regulators.
  • Corporate and Transactional.   Advising on corporate establishment, cross-border and multi-jurisdictional transactions, labor and employment, due diligence, compliance investigations, IP valuation and licensing, assignments and acquisitions, franchising, distributorship, technology transfer, and tax and customs issues.
  • IP Registration.   Strategic portfolio management of patents, trademarks, trade secrets, copyright, and geographical indications, including IP search, registration, freedom-to-operate opinions, recordal, and prosecution.
  • IP Enforcement and Litigation.   Advising on pre-litigation and arbitration, IP litigation and strategy, validity challenges and invalidations, product liability, consumer complaints and recalls, and monitoring for infringing products in the market or under the application process.

Experience

  • Acted as counsel to a major pharmaceutical company by liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.
  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.
  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.
  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
  • Secured an export license for the client in an efficient manner, as required by the head of the product group.
  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.
  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.
  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application.
  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.
  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.

PROFESSIONALS

RELATED INSIGHTS

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.
August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
August 10, 2026
The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT. Key provisions of the new circular are discussed below. Five-Year Data Exclusivity and Five-Month Public Disclosure Framework Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted. Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights. Simplified Requirements for Foreign Legal Documents Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities. In addition, the new circular permits the submission of electronic notarized copies of legal documents
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
AWARDS & RANKINGS
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.
March 2, 2026
Tilleke & Gibbins has been shortlisted for two prestigious recognitions in the Chambers Asia-Pacific and Greater China Region Honours 2026. The firm received nominations for both Thailand Firm of the Year and Vietnam Firm of the Year. The Chambers Asia-Pacific and Greater China Region Honours recognize preeminent law firms demonstrating outstanding work, impressive strategic growth, and excellence in client service across the region. The Thailand nomination marks the firm’s sixth consecutive shortlisting and twelfth since 2010. For Vietnam, this is the third consecutive year the firm has been recognized. The winners will be announced at an awards ceremony in Hong Kong on May 28, 2026. To learn more about the Chambers Asia-Pacific and Greater China Region Honours 2026 and browse the full list of nominations, please visit the Chambers and Partners website.
January 15, 2026
Tilleke & Gibbins has demonstrated continued excellence across all six jurisdictions where the firm operates in the 2026 edition of the Legal 500 Asia-Pacific rankings. The recently released rankings showcase the firm’s outstanding performance with 29 practice area recognitions and 34 individual rankings—an increase from 30 individual recognitions in 2025.
December 17, 2025
Tilleke & Gibbins is pleased to announce that Jay Cohen and John Frangos have been recognized in the Lexology Index: Client Choice 2026 report as two of the world’s leading practitioners in their respective fields. Jay Cohen is recognized for his work in franchising, while John Frangos is cited for outstanding work in investigations. The Client Choice awards highlight lawyers who stand out for excellence in client care and the quality of their service. Established in 2005, Client Choice is distinctive in that winners are selected solely based on nominations from corporate counsel. Only one lawyer per practice area is recognized in each jurisdiction. This recognition reflects sustained commitment that Jay and John have shown to delivering practical, client-focused advice and achieving strong outcomes across complex and often sensitive matters. The full Lexology Index: Client Choice 2026 results are available on the Lexology website.