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 5505
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

Areeya Pornwiriyangkura

T:+66 2653 5882

E-mail

Associate
Bangkok

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 5617

E-mail

Consultant
Hanoi

Giang Thi Huong Tran

T:+84 4 3772 5626

E-mail

Consultant
Hanoi

Irene Djalim

T:+6221 2971 8001

E-mail

Consultant
Jakarta

Jim Dao

T:+84 8 3936 2062

E-mail

Consultant
Ho Chi Minh City
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Datesort icon Title
November 19, 2013

Chambers Asia Pacific Awards 2014: Tilleke & Gibbins Shortlisted for Thailand Law Firm of the Year

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins has been nominated by Chambers and Partners for the Thailand Law Firm of the Year award. Four other firms were shortlisted for the award, with the winner set to be announced...

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November 8, 2013

Dr. Atthachai Homhuan Explains the Dark Side of Online Pharmacies in BigChilli Interview

Atthachai Homhuan

Ordering drugs from online pharmacies can be a risky ordeal. Not only can they cause serious harm to your health, but they may expose you to credit card fraud and put you in a difficult position...

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September 24, 2013

WIPR: Thailand Updates Patent Examination Guidelines

Atthachai Homhuan, Wongrat Ratanaprayul

Thailand’s guidelines for examining patents are in dire need of clarification. Thai patent examiners have been held back by unclear guidance, which has contributed toward long delays in...

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June 19, 2013

Asian Legal Business: Tilleke & Gibbins Voted Employer of Choice 2013 in Thailand and Vietnam

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins is one of the best employers in the legal marketplace in Thailand and Vietnam, according to a recent survey of legal professionals across Asia. In its June 2013 cover story...

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May 9, 2013

Suebsiri Taweepon to Speak at Personal Care Summit on Counterfeit Products and Threats to the Market

Suebsiri Taweepon

This Personal Care Summit conference will provide attendees with a complete and contemporary overview of the current personal care market, including cosmetics, skincare, and haircare. The...

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Datesort icon Title
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

Huong Lan Nguyen, 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

Michael K. Lee, Huong Lan Nguyen, 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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January 7, 2015

Lex Mundi Guide to Doing Business in Thailand 2015

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

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