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: +66 2653 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 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

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 8811 ext. 107

E-mail

Consultant
Hanoi

David Mol

T:+855 23 964 210

E-mail

Consultant
Phnom Penh

Dino Santaniello

T:+66 2653 5607

E-mail

Consultant
Bangkok
Vientiane
Yangon

Giang Thi Huong Tran

T:+84 4 3772 5626

E-mail

Consultant
Hanoi
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Datesort icon Title
January 26, 2016

Chambers Asia-Pacific Awards 2016: Tilleke & Gibbins Nominated as Thailand Law Firm of the Year

Tilleke & Gibbins has been nominated to win the highly coveted Thailand Law Firm of the Year Award 2016 by Chambers Asia-Pacific. The winner of this year’s award will be announced at...

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November 18, 2015

Asialaw Profiles 2016: Tilleke & Gibbins Receives Top Rankings in Four Countries

Asialaw Profiles, a guide to the Asia-Pacific’s leading domestic and regional law firms, has released its annual rankings, and Tilleke & Gibbins has received top rankings in Thailand...

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October 8, 2015

Asian-Mena Counsel: Tilleke & Gibbins Receives Firm of the Year Awards in Thailand and Vietnam

Asian-Mena Counsel  magazine has named Tilleke & Gibbins as Thailand Firm of the Year in Intellectual Property and Vietnam Firm of the Year in Life Sciences in its “In-House...

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October 5, 2015

Euromoney Asia Women in Business Law Awards 2015: Tilleke & Gibbins Nominated in Four Categories

Darani Vachanavuttivong, Tiziana Sucharitkul, Sukontip Jitmongkolthong

Tilleke & Gibbins has been shortlisted in four categories in the Euromoney Legal Media Group Asia Women in Business Law Awards 2015. The awards recognize leading individuals in practice area...

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September 28, 2015

Tilleke & Gibbins Named Domestic Law Firm of the Year at TrustLaw Awards

Based on our “effort and enthusiasm in supporting pro bono clients over the last year,” Tilleke & Gibbins has been named the “2015 Domestic Law Firm of the Year” at this year’s TrustLaw Awards...

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Datesort icon Title
January 15, 2016

Lex Mundi Guide to Doing Business in Thailand 2016

The Guide to Doing Business in Thailand, published by Tilleke & Gibbins in association with Lex Mundi, provides a comprehensive overview of the legal...

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November 16, 2015

Distribution and Marketing of Drugs (Second Edition) – Thailand Chapter

Alan Adcock, Siraprapha Rungpry

The second edition of Distribution and Marketing of Drugs  provides an overview of the main legal issues involved in pharmaceutical sales in 28 jurisdictions worldwide. The Thailand...

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November 16, 2015

Distribution and Marketing of Drugs (Second Edition) – Vietnam Chapter

Tu Ngoc Trinh, Huong Lan Nguyen

The 2015 edition of Distribution and Marketing of Drugs, a guide to the distribution and marketing of drugs in 28 jurisdictions around the world, has been published. Each chapter provides...

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November 3, 2015

Vietnam: Drug Innovator Scores Win

Loc Xuan Le, Linh Duy Mai

On September 11, 2015, the Drug Administration of Vietnam (DAV) issued a decision to withdraw the marketing authorizations (MAs) for nine pharmaceutical products on the market. While this is a...

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October 5, 2015

Amendments to Cosmetics Act Introduce Renewal Requirements and Fees

Alan Adcock, Atthachai Homhuan

New amendments to Thailand’s Cosmetics Act aim to update the decades-old law and harmonize the country’s cosmetics control system with the systems of other ASEAN countries.

Previously, a...

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