Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2653 5871
T: +66 2653 5610
T: +84 8 3936 2069

T: +6221 2971 8099
T: +856 21 262 355
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 2653 5871

E-mail

Partner
Bangkok

Darani Vachanavuttivong

T:+66 2653 5888

E-mail

Partner
Bangkok
Vientiane
Yangon

Michael K. Lee

T:+84 8 3936 2069

E-mail

Partner
Ho Chi Minh City

Anh Thi Phuong Pham

T:+84 8 3936 2077

E-mail

Associate
Ho Chi Minh City

Areeya Pornwiriyangkura

T:+66 2653 5882

E-mail

Associate
Bangkok

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

Tu Ngoc Trinh

T:+84 4 3772 5556

E-mail

Associate
Hanoi

Cuong Hong Dang

T:+84 4 3772 5617

E-mail

Consultant
Hanoi

Giang Thi Huong Tran

T:+84 4 3772 5626

E-mail

Consultant
Hanoi
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Datesort icon Title
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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May 6, 2015

Alan Adcock and Areeya Pornwiriyangkura to Present at Asian Food Franchising Forum

Alan Adcock, Areeya Pornwiriyangkura

Alan Adcock, a partner and deputy director of the intellectual property department at Tilleke & Gibbins, and Areeya Pornwiriyangkura, an attorney-at-law in Tilleke & Gibbins’ intellectual...

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April 16, 2015

Asian Legal Business: Tilleke & Gibbins Voted Employer of Choice 2015 in Thailand

Tiziana Sucharitkul, Darani Vachanavuttivong

For the third year in a row, Asian Legal Business  has named Tilleke & Gibbins “Employer of Choice” in Thailand, solidifying our reputation as one of Asia’s best law firms to...

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March 16, 2015

ALB Power List 2015: Tilleke & Gibbins Ranked Among Top Law Firms in Asia

Placing our firm at the pinnacle of Asia’s legal market, Asian Legal Business  has ranked Tilleke & Gibbins among the top ten “domestic” law firms in Asia in the inaugural...

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Datesort icon Title
July 14, 2015

PLC Life Sciences Multi-Jurisdictional Guide 2015/16 – Thailand Chapter

Alan Adcock, Atthachai Homhuan, Areeya Pornwiriyangkura, Siraprapha Rungpry

Practical Law Company has published the latest edition of the PLC Life Sciences Multi-jurisdictional Guide, a Q&A-style guide which provides country-specific analysis of the current...

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July 14, 2015

PLC Life Sciences Multi-Jurisdictional Guide 2015/16 – Vietnam Chapter

Tu Ngoc Trinh, Huong Lan Nguyen, Hien Thi Thu Vu

The latest edition of the PLC Life Sciences Multi-jurisdictional Guide  provides a Q&A-style analysis of the current regulatory framework surrounding the life sciences industry....

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June 29, 2015

The International Comparative Legal Guide to: Pharmaceutical Advertising 2015 – Vietnam Chapter

Kien Trung Trinh, Tu Ngoc Trinh

Kien Trung Trinh, senior attorney-at-law, and Tu Ngoc Trinh, attorney-at-law, in Tilleke & Gibbins’ Hanoi office, have co-authored the Vietnam chapter of The International Comparative...

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June 3, 2015

Global Agriculture Law (1st Ed.) – Vietnam Chapter

Kien Trung Trinh, Dung Thi Kim Vu, Linh Duy Mai

Global Agriculture Law (1st Ed.), a guide that presents a Q&A-style overview of agriculture law in 22 jurisdictions around the world, has been published. The Vietnam chapter of the...

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June 3, 2015

Global Agriculture Law (1st Ed.) – Thailand Chapter

The first edition of Global Agriculture Law, a Q&A-style guide that provides detailed overviews of agriculture law worldwide, has been published. The guide covers key practical issues...

Read more