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.

Datesort icon Title
November 19, 2020

Alan Adcock Quoted in INTA Article on Cannabis Legalization

Alan Adcock

Alan Adcock, partner and deputy director of Tilleke & Gibbins’ intellectual property practice,...

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November 13, 2020

Tilleke & Gibbins Named Thailand Firm of the Year in Who’s Who Legal Awards 2020

Tilleke & Gibbins has been named Thailand Firm of the Year at the Who’s Who Legal Awards 2020, held on November 12, 2020. Notably, this award marks the fifth consecutive...

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November 10, 2020

Tiziana Sucharitkul Speaks at IBA 2020

Tiziana Sucharitkul

On November 19, 2020, Tiziana Sucharitkul, co-managing partner at Tilleke & Gibbins and director of the firm's regional disputes resolution practice, will join a panel of managing partners...

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November 6, 2020

Tilleke & Gibbins Nominated for Three Women in Business Law Awards Asia-Pacific 2020

Tilleke & Gibbins has been nominated in three firm-wide categories in the Women in Business Law Awards Asia-Pacific 2020. The awards, which are organized each year by Euromoney to recognize...

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October 29, 2020

AMCHAM Thailand Recognizes Tilleke & Gibbins at 2020 CSR Excellence Awards

On Tuesday, October 27, Tilleke & Gibbins was singled out for an award for exceptional corporate social responsibility (CSR) work during the past 12 months at the 2020 CSR Excellence Awards,...

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January 30, 2019

Decree 169: New Regulations on Medical Devices in Vietnam

Mai Thi Le, Hien Thi Thu Vu

On December 31, 2018, the Vietnamese government promulgated Decree No. 169/2018/ND-CP (Decree 169), amending Decree No. 36/2017/ND-CP (Decree 36) on medical device management. Decree 169 took...

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December 6, 2018

Growing Hemp in Thailand Is Now Permissible

Atthachai Homhuan, Siradapat Ratanakorn

From regulation and production to research and development, product development, and marketing, the hemp (Cannabis sativa) industry is set to outperform most expectations in the very near...

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December 6, 2018

Thai FDA Requires Proof of Authorization for Cosmetic Product Notification

Atthachai Homhuan

On November 1, 2018, a notification came into force requiring a letter of authorization or license agreement to be submitted to the Thai Food and Drug Administration (“Thai FDA”) with any...

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November 5, 2018

Myanmar-Language Labeling Required on Wide Range of Products

Yuwadee Thean-ngarm

Myanmar’s Central Committee for Consumer Protection issued Notification 1/2018 on October 26, 2018, which requires labels containing certain information in Myanmar language, jointly or combined...

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September 5, 2018

Practical Law Life Sciences Global Guide: Pharmaceutical IP and Competition Law in Vietnam

Mai Thi Le, Hien Thi Thu Vu, Chuyen Hong Huu Le

Experts from Tilleke & Gibbins have authored the Vietnam chapters of the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in...

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