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
August 16, 2016

Vitafoods Asia: Siradapat Ratanakorn and Nitat Sinsereekul to Speak on Food Supplement Regulations in Thailand

Siradapat Ratanakorn, Nitat Sinsereekul

Siradapat Ratanakorn and Nitat Sinsereekul, consultants in Tilleke & Gibbins’ regulatory affairs group, will speak on the topic “Thailand Food Supplement Regulations – What Businesses Should...

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May 6, 2016

IP Lunch Talk: Tilleke & Gibbins and NIA to Hold Discussion on Healthcare Business

Atthachai Homhuan

The key drivers of healthcare product investment are the effective protection of intellectual property rights and compliance with the law. Protection of IP rights and obtaining market...

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April 28, 2016

ALB SEA Law Awards 2016: Tilleke & Gibbins Nominated in Three Firm of the Year Categories

Darani Vachanavuttivong, Tiziana Sucharitkul, Thomas J. Treutler

The nominees of Asian Legal Business’s Southeast Asia Law Awards 2016 have been announced, and Tilleke & Gibbins has secured nominations in three categories, as follows:

April 18, 2016

Tilleke & Gibbins Named ALB Employer of Choice 2016 in Thailand and Vietnam

Tiziana Sucharitkul, Darani Vachanavuttivong

Tilleke & Gibbins has won the “Employer of Choice” award for 2016 in both Thailand and Vietnam, as determined by Asian Legal Business  magazine. For Thailand, this is the fourth...

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April 13, 2016

Tilleke & Gibbins Wins 2016 Who’s Who Legal Country Award for Thailand

Who’s Who Legal has named Tilleke & Gibbins as the winner of the 2016 Who’s Who Legal Country Award for Thailand. With the awards ceremony now in its third year, Tilleke & Gibbins was the...

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Datesort icon Title
August 30, 2016

Nutrition Claims in Thailand

Nitat Sinsereekul

“Let food be your medicine" is a common mantra recited by those in the food business. In Thailand, many food products are fortified with nutrients such as vitamins, minerals and amino acids, and...

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August 26, 2016

Vietnam’s New Pharmaceutical Law

Chuyen Hong Huu Le, Kien Trung Trinh

The National Assembly of Vietnam adopted a new Law on Pharmacy on June 4, 2016. The new law will take effect on January 1, 2017, replacing the current version which was passed in 2005. In an...

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August 26, 2016

Product Labeling in Laos: New Regulations Require Local Language on Packaging

Dino Santaniello

The Lao government has recently stepped up its efforts to raise public awareness of health issues and the quality of products sold in the market. The impetus behind the government’s actions is...

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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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