Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 24 3772 5606
T: +855 23 964 210
T: +6221 2971 8099
T: +66 2056 5871
T: +95 1 255 208

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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Name Position Office

Alan Adcock

T:+66 2056 5871

E-mail

Partner
Bangkok

Darani Vachanavuttivong

T:+66 2056 5888

E-mail

Partner
Bangkok
Vientiane
Yangon

Kien Trung Trinh

T:+84 24 3772 5567

E-mail

Partner
Hanoi

Chuyen Hong Huu Le

T:+84 28 3936 2079

E-mail

Associate
Ho Chi Minh City

Hien Thi Thu Vu

T:+84 24 3772 5606

E-mail

Associate
Hanoi

Niko Myint Soe

T:+95 1 255 208

E-mail

Associate
Yangon

Pichrotanak Bunthan

T:+855 23 964 210

E-mail

Associate
Phnom Penh

San Chaithiraphant

T:+66 2056 5640

E-mail

Associate
Bangkok

Tu Ngoc Trinh

T:+84 24 3772 5556

E-mail

Associate
Hanoi

Cuong Hong Dang

T:+84 24 3772 8811 ext. 107

E-mail

Consultant
Hanoi
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Datesort icon Title
January 12, 2018

Chambers Asia-Pacific Awards 2018: Tilleke & Gibbins Earns Nomination for Thailand Law Firm of the Year

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins has been nominated as Thailand Law Firm of the Year in the Chambers Asia-Pacific Awards 2018. The firm has earned nominations for the award seven times since 2010, and...

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January 8, 2018

Tilleke & Gibbins Credited by Chemlinked in Guide to Food Regulation in Vietnam

Hien Thi Thu Vu

Chemlinked has credited Tilleke & Gibbins as the lead contributor in its guide to food regulations in Vietnam. The guide forms part of Chemlinked's Foodpedia  tool, which...

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January 8, 2018

Tilleke Promotes Four New Partners in Thailand and Vietnam

Athistha (Nop) Chitranukroh, Kien Trung Trinh, Loc Xuan Le, Vinh Quoc Nguyen

Regional Southeast Asian law firm Tilleke & Gibbins is pleased to announce the promotion of four new members of the firm’s partnership in Thailand and Vietnam, effective January 2018.

...

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December 6, 2017

Webinar: Thomas Treutler to Speak on Regulatory Developments in Vietnam and Thailand

Thomas J. Treutler

Partner Thomas J. Treutler will provide an update on the latest developments in the life sciences and healthcare sector in Vietnam and Thailand at a webinar organized by CMS and the Lifesciences...

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December 4, 2017

Thomas Treutler to Speak on Foreign Investment Challenges in Vietnam

Thomas J. Treutler

On December 7, Thomas J. Treutler, partner and managing director of Tilleke & Gibbins’ Vietnam offices, will speak on the development of IT and digital technology in Vietnam at a workshop on “...

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Datesort icon Title
November 25, 2016

Intellectual Property Linkage: Connecting IP Offices with Regulators

Alan Adcock

Intellectual property (IP) linkage refers to connecting an IP office, through open communication lines and complementary processes, to other government agencies that work on IP. This generally...

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November 14, 2016

Food Regulations and Enforcement in Thailand

Siradapat Ratanakorn

Food Regulations and Enforcement in Thailand, a chapter in the Reference Module in Food Science  book, published by Elsevier, provides an overview of food laws and enforcement...

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October 25, 2016

Medical Device Regulations Updated in Vietnam

Kien Trung Trinh

On May 15, 2016, shortly before the new Law on Pharmacy was adopted, the Vietnamese government issued Decree No. 36/2016/ND-CP on the...

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October 25, 2016

Effects of the TPP on Vietnam’s Pharmaceutical Industry

John Frangos, Chuyen Hong Huu Le

On February 4, 2016, Vietnam and 11 other countries signed the Trans-Pacific Partnership (TPP). The TPP includes Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, the...

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October 25, 2016

The Importance of Patents in Drug Tenders in Vietnam

Hien Thi Thu Vu

With a population of over 90 million, fast-paced economic growth, and an increasing standard of living, Vietnam has become a market with great potential for original brand name drugs. These drugs...

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