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
July 31, 2017

Tilleke & Gibbins Nominated for Three TrustLaw Pro Bono Awards

In recognition of Tilleke & Gibbins’ pro bono practice, our firm has been nominated for the following awards at the 2017 TrustLaw Awards:

May 23, 2017

Who’s Who Legal Recognizes Tilleke & Gibbins with 2017 Country Award for Thailand

Tiziana Sucharitkul, Darani Vachanavuttivong

Tilleke & Gibbins has won the 2017 Who’s Who Legal Country Award for Thailand at a ceremony that took place at Plaisterers’ Hall in London on May 15. This is the second year that the Thailand...

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April 12, 2017

Tilleke & Gibbins Named ALB Employer of Choice 2017

For the fifth year in a row, Tilleke & Gibbins has been named “Employer of Choice” in Thailand in a survey conducted by Asian Legal Business.

The rankings were determined...

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April 12, 2017

ALB Southeast Asia Law Awards 2017: Tilleke & Gibbins Earns Nominations in Four Categories

Tilleke & Gibbins has been nominated for two national categories and two regional categories in the Asian Legal Business  Southeast Asia Law Awards 2017. This year’s winners will...

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February 1, 2017

Chambers Asia-Pacific Awards 2017: Tilleke & Gibbins Top Contender for Thailand Law Firm of the Year Award

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins has been nominated for the Thailand Law Firm of the Year Award 2017 by Chambers Asia-Pacific. The firm has been nominated for the award six times since 2010, and was...

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Datesort icon Title
June 3, 2015

Global Agriculture Law (1st Ed.) – Thailand Chapter

The first edition of Global Agriculture Law, a Q&A-style guide that provides detailed overviews of agriculture law worldwide, has been published. The guide covers key practical issues...

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May 28, 2015

Animal Feed Control: An Update on Thailand’s Legislation

Atthachai Homhuan

Thailand’s roadmap of food safety, which was approved in 2004, aims to promote the Kingdom as the “kitchen of the world.” Animal feed, i.e., food given to farm animals, plays a major role in the...

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May 14, 2015

Pharmaceutical Parallel Imports: A Solution or a Problem?

Loc Xuan Le, Linh Duy Mai

As a developing country with a large population, Vietnam has long viewed parallel imports as an effective antidote to the high price of innovator drugs. The parallel importation of medicines for...

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May 14, 2015

Circular 44 Updates Drug Registration Requirements

Kien Trung Trinh

To ensure harmony in regulations between ASEAN countries as well as tighten the management of drug registration, the Ministry of Health (MOH) issued Circular No. 44/2014/TT-BYT dated November 25,...

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May 14, 2015

Foreign Drug Company and Local Distributor Relationships in Vietnamese Public Drug Procurement

Kien Trung Trinh

Vietnam’s Drug Distribution Policy

Under its WTO commitments, Vietnam agreed to allow foreign-invested entities (FIEs) to conduct distribution services (i.e., commission...

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