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

David Mol

T:+855 23 964 210

E-mail

Consultant
Phnom Penh

Dino Santaniello

T:+856 21 262 355

E-mail

Consultant
Vientiane
Bangkok

Giang Thi Huong Tran

T:+84 24 3772 5626

E-mail

Consultant
Hanoi

Irene Djalim

T:+6221 2971 8001

E-mail

Consultant
Jakarta

Sher Hann Chua

T:+95 1 255 208

E-mail

Consultant
Yangon

Siraprapha Rungpry

T:+66 2056 5874

E-mail

Consultant
Bangkok

Wongrat Ratanaprayul

T:+6221 2971 8099

E-mail

Consultant
Jakarta
Bangkok

Dung Thi Kim Vu

T:+84 24 3772 5554

E-mail

Patent Specialist
Hanoi

Salil Siriwat

T:+66 2056 5670

E-mail

Patent Specialist
Bangkok

Atthachai Homhuan

T:+66 2056 5610

E-mail

Regulatory Consultant
Bangkok
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Datesort icon Title
January 12, 2018

Chambers Asia-Pacific Awards 2018: Tilleke & Gibbins Earns Nomination for Thailand Law Firm of the Year

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins has been nominated as Thailand Law Firm of the Year in the Chambers Asia-Pacific Awards 2018. The firm has earned nominations for the award seven times since 2010, and...

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January 8, 2018

Tilleke & Gibbins Credited by Chemlinked in Guide to Food Regulation in Vietnam

Hien Thi Thu Vu

Chemlinked has credited Tilleke & Gibbins as the lead contributor in its guide to food regulations in Vietnam. The guide forms part of Chemlinked's Foodpedia  tool, which...

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January 8, 2018

Tilleke Promotes Four New Partners in Thailand and Vietnam

Athistha (Nop) Chitranukroh, Kien Trung Trinh, Loc Xuan Le, Vinh Quoc Nguyen

Regional Southeast Asian law firm Tilleke & Gibbins is pleased to announce the promotion of four new members of the firm’s partnership in Thailand and Vietnam, effective January 2018.

...

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December 6, 2017

Webinar: Thomas Treutler to Speak on Regulatory Developments in Vietnam and Thailand

Thomas J. Treutler

Partner Thomas J. Treutler will provide an update on the latest developments in the life sciences and healthcare sector in Vietnam and Thailand at a webinar organized by CMS and the Lifesciences...

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December 4, 2017

Thomas Treutler to Speak on Foreign Investment Challenges in Vietnam

Thomas J. Treutler

On December 7, Thomas J. Treutler, partner and managing director of Tilleke & Gibbins’ Vietnam offices, will speak on the development of IT and digital technology in Vietnam at a workshop on “...

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Datesort icon Title
December 20, 2017

Vietnam Pharma Update 2017

Tilleke & Gibbins’ fourth annual Vietnam Pharma Update  provides a compilation of articles on the life sciences sector in Vietnam written by our lawyers, IP executives, and...

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November 28, 2017

Indonesia Implementing Halal Assurance System

Indah Handayani

The private sector in Indonesia has been vocal about their concern for the government’s plan to make halal certification mandatory, believing that this requirement will add a greater burden to...

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November 28, 2017

Thailand Food and Drug Administration Unveils New Official Fees

Atthachai Homhuan

Higher life expectancy, a growing middle-income population, and the government’s policy of promoting access to medicine are key drivers boosting demand for healthcare-related businesses in...

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October 31, 2017

ChemLinked Foodpedia Article: Food Regulation in Thailand

Alan Adcock

Foodpedia articles, published online on the ChemLinked Chemical Portal by REACH24H Consulting Group, provide an overview of the food industries in eight jurisdictions in Asia. An article on Food...

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September 22, 2017

PLC Life Sciences Global Guide 2017 – Vietnam Chapter

Hien Thi Thu Vu, Tu Ngoc Trinh

Pharmaceutical experts from Tilleke & Gibbins authored the Vietnam chapters of the latest edition of the PLC Life Sciences Global Guide. PLC’s popular guides provide a comparative...

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