Life Sciences / Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 24 3772 5633
T: +84 24 3772 5606
T: +855 23 964 210
T: +6221 2971 8099
T: +66 2056 5871
T: +95 1 8255 208

Tilleke & Gibbins paves the way for life sciences clients to enter and excel in markets throughout Southeast Asia. From research and development and clinical trials to registration and market entry to commercialization and technology transfer, we assist leading and soon-to-be-leading companies through every stage of a product’s life cycle. And when shifting government policies threaten progress, we step in, build coalitions, and facilitate positive change.

Our dynamic group is built on decades of practice in the region and is committed to keeping pace with discovery and innovation. Our client teams are led by experienced attorneys and specialized practitioners and include, as appropriate to the client and its industry, pharmacists, agricultural consultants, and other regulatory specialists. We guide our clients through the layers of formal and informal rules, policies, and procedures, and help our clients forge constructive relationships with regulatory authorities.

Tilleke & Gibbins’ Regulatory Affairs group consistently earns the trust of top companies in the pharmaceutical, cosmetics, consumer products, food and beverages, biotech, medical devices, veterinary products, and other life sciences sectors. Our practice spans the following disciplines:  

  • Clinical Trials and Consumer Testing 
  • Food and Drug Administration (FDA) Registration
  • FDA Import, Export, and Manufacturing Licenses
  • Ministry of Agriculture (MOA) Crop Care Registration
  • MOA Animal, Aquatic, and Hazardous Substance Registration
  • MOA Import, Export, and Manufacturing Licenses
  • Holding Licenses 
  • Regulatory Compliance and Maintenance 
  • Labeling and Advertising Clearance
  • Intellectual Property
Among our recent matters, we have:
  • Acted as counsel to a major pharmaceutical company, which representation included 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.

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September 9, 2020

Tilleke & Gibbins Shortlisted for Four Indonesian Law Awards 2020

Thomson Reuters publication Asian Legal Business  (ALB ) has announced its shortlist for the Indonesian Law Awards 2020, and Tilleke & Gibbins...

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September 3, 2020

Tilleke & Gibbins Earns 15 Nominations for ALB’s 2020 SE Asia Law Awards

Asian Legal Business  (ALB ) has announced its nominations for the 2020 SE Asia Law Awards, and Tilleke & Gibbins has received a record 15 nominations this...

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August 27, 2020

Tilleke & Gibbins Wins Thailand Firm of the Year in Asialaw Awards 2020

In the recently announced Asialaw Awards 2020, Tilleke & Gibbins was named Thailand Firm of the Year in the Client Service Excellence category, in recognition of the firm’...

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August 18, 2020

Tilleke & Gibbins Named to Inaugural ALB Trailblazers List

Tilleke & Gibbins has been named to Asian Legal Business’ inaugural ALB Trailblazers list, which recognizes firms that are applying innovative strategies to deal...

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July 14, 2020

Tilleke & Gibbins Highlighted in WTR Article on Diversity and Inclusion in Asian Law Firms

In a research project to celebrate Pride Month 2020, World Trademark Review  (WTR) recently set out to explore the landscape of diversity and inclusion initiatives in...

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November 17, 2020

Practical Law Life Sciences Global Guide: Medicinal Product Regulation and Product Liability in Thailand (November 2020)

Alan Adcock, Atthachai Homhuan, Siraprapha Claassen

The Thailand updates to the Practical Law's Life Sciences Global Guide  have been published, with attorneys from Tilleke & Gibbins providing answers for the Medicinal Product...

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November 17, 2020

Practical Law Life Sciences Global Guide: Pharmaceutical IP and Competition Law in Thailand (November 2020)

Alan Adcock, Atthachai Homhuan, Siraprapha Claassen

The Thailand updates to Practical Law’s Life Sciences Global Guide  have been released online, with legal practitioners from Tilleke & Gibbins contributing the Pharmaceutical...

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September 1, 2020

Thailand Readies Draft Notification to Allow Hemp-Based Ingredients for Food Innovation

San Chaithiraphant, Atthachai Homhuan

The cannabis industry in Thailand took its first concrete step in February of 2019, when medical cannabis was unexpectedly legalized. In August 2019, a Ministry of Public Health (MOPH)...

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June 25, 2020

Practical Law: Agricultural Law in Thailand 2020

Chaiwat Keratisuthisathorn, Chanchai Jhongsathit, Michael Ramirez, Salil Siriwat, Siradapat Ratanakorn, Varapa Aurat

Practical Law has published an updated online version of Agricultural Law in Thailand, a Q&A-style guide that provides detailed overviews of the law affecting...

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June 15, 2020

Thailand Takes Steps to Ensure Availability of High-Demand Medical Supplies

Tayagorn Warathornthnakul, Kittiya Nopparatrungroj

Dealing with the COVID-19 pandemic has taken top priority for almost every country in the world. In Thailand, even though the strength of the country’s health security measures has been ranked...

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