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

Chuyen Hong Huu Le

T:+84 28 3936 2079

E-mail

Associate
Ho Chi Minh City

Daraboth Kim

T:+855 23 964 210

E-mail

Associate
Phnom Penh

Kien Trung Trinh

T:+84 24 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 24 3772 5556

E-mail

Associate
Hanoi

Cuong Hong Dang

T:+84 24 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
January 24, 2007

Thailand: Critical Need for New Investment

This extensive feature covers a wide range of issues for Thailand’s pharmaceutical industry. Comments from Edward Madden and Edward Kelly of Tilleke & Gibbins are included in the feature.

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February 2, 2007

Interview with Edward Kelly, Edward Madden, and Tiziana Sucharitkul

Tiziana Sucharitkul

This interview of Edward Kelly, Edward Madden, and Tiziana Sucharitkul covers a broad range of topics dealing with the overall intellectual property situation in Thailand, the impact of expected...

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March 27, 2007

Protecting Intellectual Property: A Wise Move in Protecting Brand Asset

This article—written in English and published alongside a Thai translation—is aimed at Thai owners of intellectual property. In an interview, Edward Kelly of Tilleke & Gibbins provides...

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March 21, 2008

Success by the Book

Darani Vachanavuttivong, Tiziana Sucharitkul

This article provides an introduction to Tilleke & Gibbins based on the firm’s winning the prestigious International Law Office Client Choice Award 2007 for Thailand.

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February 13, 2009

Registration Firms Explore Outsourcing Options

Alan Adcock

This World Intellectual Property Review article is based on an in-depth interview of Paul Russell and Alan Adcock. The article discusses the increasingly popular trend to outsource IP...

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Datesort icon Title
April 25, 2006

Yesteryear – Bangkok in 1956: What Was It Like When AMCHAM Thailand Was Founded?

David Lyman

In this text of a presentation for the 50th anniversary of the American Chamber of Commerce in Thailand, David Lyman reflects on the changes he has observed in Thailand in the 50 years since...

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June 4, 2007

A Guide to the Alcohol Ad Ban

Michael Ramirez

Recently the Thai government has expressed its intent to enforce a total ban on alcohol advertising in the Kingdom. The ban, which was originally introduced by the Thai Food and Drug...

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October 19, 2007

Doing Business in Vietnam

John King, Thomas J. Treutler

On the heels of its 2006 entry into the WTO, Vietnam’s economy continues to show high growth and is generally considered the second fastest growing economy in Asia behind China. This article...

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December 4, 2007

Data Protection Under Trade Secrets Law

Siraprapha Rungpry

In 2002, Thailand adopted the Trade Secrets Act, which contains a provision intended to safeguard the confidenti­ality of marketing approval data submitted to the Food and Drug Administration (FDA...

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January 23, 2008

Gaps in Data Exclusivity under Trade Secrets Law

Siraprapha Rungpry

In 2002, Thailand adopted the Trade Secrets Act which contains a provision intended to safeguard the confidentiality of marketing approval data submitted to the Thai Food and Drug Administration (...

Read more