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
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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August 14, 2015

Tilleke & Gibbins Nominated for TrustLaw Pro Bono Award

John King

In recognition of Tilleke & Gibbins’ pro bono practice, our firm has been nominated as “2015 Domestic Law Firm of the Year” at this year’s TrustLaw Awards. Our nomination in this category is...

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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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Datesort icon Title
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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April 11, 2016

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

Michael Ramirez, Nwe Oo

The Myanmar chapter of Doing Business, a guide published by Practical Law Company in association with Lex Mundi, presents a comprehensive Q&A-style overview of doing business in...

Read more

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...

Read more