Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 8 3936 2069
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

Michael K. Lee

T:+84 8 3936 2069

E-mail

Partner
Ho Chi Minh City

Chuyen Hong Huu Le

T:+84 8 3936 2079

E-mail

Associate
Ho Chi Minh City

Kien Trung Trinh

T:+84 4 3772 5567

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

Tu Ngoc Trinh

T:+84 4 3772 5556

E-mail

Associate
Hanoi

Cuong Hong Dang

T:+84 4 3772 8811 ext. 107

E-mail

Consultant
Hanoi

David Mol

T:+855 23 964 210

E-mail

Consultant
Phnom Penh
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Datesort icon Title
August 13, 2015

Alan Adcock to Serve as Panelist on Agribusiness and Food at ASEAN-EU Business Summit

Alan Adcock

Alan Adcock, partner and deputy director of the intellectual property department at Tilleke & Gibbins, will participate in a panel discussion on agribusiness and food at the “4th ASEAN-EU...

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August 5, 2015

AMCHAM Thailand Event on August 13: FDA and Livestock Development

Alan Adcock, Atthachai Homhuan, Siradapat Ratanakorn

Alan Adcock, partner and deputy director of the intellectual property department, Dr. Atthachai Homhuan, manager of regulatory affairs, and Siradapat Ratanakorn, consultant, in Tilleke &...

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August 4, 2015

Cambodia: Tilleke & Gibbins Opens New Office in Phnom Penh

Tilleke & Gibbins is delighted to announce that we have opened a new office in Phnom Penh, Cambodia. Building on our firm’s presence in Indonesia, Laos, Myanmar, Thailand, and Vietnam, this...

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June 13, 2015

Lex Mundi Pro Bono Foundation Honors Tilleke & Gibbins

The Sixth Annual Lex Mundi Pro Bono Foundation Awards were presented during the 2015 Lex Mundi Leadership Summit and Annual Conference in New Orleans, and Tilleke & Gibbins, the Member Firm...

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June 9, 2015

ALB Diversity List 2015: Tilleke & Gibbins Counted Among Top Firms

Tiziana Sucharitkul, Darani Vachanavuttivong

Tilleke & Gibbins has been included in the first edition of the Diversity List, a list compiled by Asian Legal Business—forming part of the magazine’s “Women in Law” feature—that...

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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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