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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

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.
July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
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.
AWARDS & RANKINGS
May 11, 2026
Tilleke & Gibbins has continued to show excellent performance in the recently released Benchmark Litigation 2026 rankings for dispute resolution firms in the Asia-Pacific region. The rankings include two jurisdictions where Tilleke & Gibbins is active: Thailand and Vietnam. Firm Rankings A full summary of the firm’s rankings is provided below: Thailand Commercial & Transactions – Tier 1 Government & Regulatory – Tier 1 Labor & Employment – Tier 1 Intellectual Property – Tier 1 Trade & Customs – Tier 2 Vietnam Commercial & Transactions (Foreign Firms) – Tier 1 Intellectual Property (Foreign Firms) – Tier 1 Labor & Employment (International Firms) – Highly Recommended (top tier awarded in this category) White Collar Crime – Recommended (top tier awarded in this category) Energy & Construction (Foreign Firms) – Tier 2 International Arbitration – Tier 2 Individual Rankings The 2026 edition also recognizes 12 Tilleke & Gibbins lawyers in Thailand—more than any other firm in the jurisdiction—and four in Vietnam. Thailand Alongkorn Tongmee – Trade & Customs Chitchai Punsan – Commercial & Transactions Chusert Supasitthumrong – Labor & Employment John Frangos – Commercial & Transactions Noppramart Thammateeradaycho – Shipping Nuttaphol Arammuang – Intellectual Property Piyawat Vitooraporn – Commercial & Transactions Pongpalin Chantrapirom – Commercial & Transactions Suebsiri Taweepon – Intellectual Property Suruswadee Jaimsuwan – Commercial & Transactions Thawat Damsa-ard – Commercial & Transactions Tiziana Sucharitkul – Commercial & Transactions, Government & Regulatory Vietnam Duc Anh Tran – Commercial & Transactions Linh Duy Mai – Intellectual Property Loc Xuan Le – Intellectual Property Tu Anh Tran – Commercial & Transactions Benchmark Litigation’s annual research is based on interviews with dispute resolution specialists and clients, as well as analysis of recent casework and market developments. To view the full results, please visit the Benchmark Litigation websites for Thailand and Vietnam.
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.