Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2653 5871
T: +66 2653 5610
T: +84 8 3936 2069
T: +855 23 964 210
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
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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February 26, 2015

Chambers Asia-Pacific Awards 2015: Tilleke & Gibbins Nominated as Thailand Law Firm of the Year

Tilleke & Gibbins has been nominated for the Thailand Law Firm of the Year Award 2015 by Chambers Asia-Pacific. This nomination comes after the firm was honored to win the...

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December 16, 2014

Asia IP Experts 2014: Eight Tilleke & Gibbins Lawyers Recognized

Identifying the best intellectual property (IP) lawyers in Asia, Asia IP  has released the 2014 edition of Asia IP Experts, a list of leading lawyers in nine key, IP-related...

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November 14, 2014

Euromoney Asia Women in Business Law Awards 2014: Tilleke & Gibbins Honored in Three Categories

Darani Vachanavuttivong, Tiziana Sucharitkul, Sukontip Jitmongkolthong

On November 13, 2014, the Euromoney Legal Media Group hosted its annual Asia Women in Business Law Awards at the JW Marriott in Hong Kong. The firm awards were judged on the best initiatives for...

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September 29, 2014

Euromoney Asia Women in Business Law Awards 2014: Tilleke & Gibbins Shortlisted in Seven Categories

Tiziana Sucharitkul, Darani Vachanavuttivong, Kasma Visitkitjakarn, Sukontip Jitmongkolthong

On November 13, 2014, the Euromoney Legal Media Group will host its annual Asia Women in Business Law Awards at the JW Marriott in Hong Kong. The firm awards will be judged on the best initiatives...

Read more

Datesort icon Title
June 8, 2016

PLC Life Sciences Multi-Jurisdictional Guide 2016/17 – Thailand Chapter

Alan Adcock, Atthachai Homhuan, Siraprapha Rungpry

PLC Life Sciences Multi-jurisdictional Guide 2016/17  is a Q&A-style guide which provides an overview of the regulatory frameworks of the life sciences industries across multiple...

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June 8, 2016

PLC Life Sciences Multi-Jurisdictional Guide 2016/17 – Vietnam Chapter

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

Presented in a Q&A format, the PLC Life Sciences Multi-jurisdictional Guide  provides a comprehensive overview of life sciences laws and regulations in jurisdictions around the...

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May 18, 2016

Lex Mundi Guide on Health Industry Laws 2016 – Thailand Chapter

Alan Adcock, Atthachai Homhuan

Published by Tilleke & Gibbins in association with Lex Mundi, the International Guide on Health Industry Laws  provides an overview of healthcare...

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May 18, 2016

Lex Mundi Guide on Health Industry Laws 2016 – Vietnam Chapter

Michael K. Lee

The International Guide on Health Industry Laws, published by Tilleke & Gibbins in association with Lex Mundi, presents an overview of healthcare systems in 19 jurisdictions around...

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April 11, 2016

PLC Doing Business In … Multi-Jurisdictional Guide 2016 – Thailand Chapter

Darani Vachanavuttivong, Sriwan Puapondh, Kitti Thaisomboon, Michael Ramirez, David Beckstead, Napat Siri-armart

Doing Business, a Q&A-style guide published by Practical Law Company in association with Lex Mundi, presents an overview of key recent developments affecting doing business in 41...

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