Life Sciences / Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 24 3772 5633
T: +84 24 3772 5606
T: +855 23 964 210
T: +6221 2971 8099
T: +66 2056 5871
T: +95 1 8255 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 Positionsort icon Office

Chuyen Hong Huu Le

T:+84 28 628 45687

E-mail

Associate
Ho Chi Minh City

Phuong Thi Minh Tran

T:+84 28 628 45682

E-mail

Associate
Ho Chi Minh City

Hien Thi Thu Vu

T:+84 24 3772 5606

E-mail

Associate
Hanoi

Niko Myint Soe

T:+95 1 8255 208

E-mail

Associate
Yangon

San Chaithiraphant

T:+66 2056 5640

E-mail

Associate
Bangkok

Kyaw Min Tun

T:+95 1 8255 208

E-mail

Associate
Yangon

Auradee Pantumkomon Wongsaroj

T:+66 2056 5659

E-mail

Associate
Bangkok

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

Wongrat Ratanaprayul

T:+6221 2971 8099

E-mail

Consultant
Jakarta
Bangkok
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Date Titlesort icon
September 17, 2019

21 Tilleke & Gibbins Professionals Ranked in Asialaw Profiles 2020

An impressive 21 Tilleke & Gibbins practitioners are listed in the 2020 edition of Asialaw Profiles , a highly regarded guide to leading law firms and legal practitioners in the...

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May 6, 2015

Alan Adcock and Areeya Pornwiriyangkura to Present at Asian Food Franchising Forum

Alan Adcock

Alan Adcock, a partner and deputy director of the intellectual property department at Tilleke & Gibbins, and Areeya Pornwiriyangkura, an attorney-at-law in Tilleke & Gibbins’ intellectual...

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April 30, 2019

Alan Adcock and Siraprapha Rungpry Featured in Who’s Who Legal: Life Sciences 2019

Alan Adcock, Siraprapha Claassen

Tilleke & Gibbins is happy to share that two of the firm’s practitioners—Alan Adcock, partner and deputy director of intellectual property, and Siraprapha Rungpry, consultant—have been...

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April 24, 2018

Alan Adcock and Siraprapha Rungpry Recognized in Who’s Who Legal Life Sciences 2018

Alan Adcock, Siraprapha Claassen

Who’s Who Legal: Life Sciences 2018  has recognized Alan Adcock, partner and deputy director of the Tilleke...

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September 20, 2017

Alan Adcock Interviewed by Asia Manufacturing News

Alan Adcock

In a feature called “Representing the Drivers of Economic Growth,” Asia Manufacturing News interviewed Alan Adcock, partner and deputy director of Tilleke & Gibbins’ intellectual...

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Date Titlesort icon
January 23, 2017

2016 Pharmaceutical Patent Overview for Vietnam

Thomas J. Treutler, Hien Thi Thu Vu

With a population approaching 100 million, a burgeoning health care industry, increasing consumer affluence, and relatively weak competition from local pharmaceutical manufacturers, Vietnam would...

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June 4, 2007

A Guide to the Alcohol Ad Ban

Michael Ramirez

Recently the Thai government has expressed its intent to enforce a total ban on alcohol advertising in the Kingdom. The ban, which was originally introduced by the Thai Food and Drug...

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May 25, 2018

Advertisements for Medical Facilities Now Require Preapproval in Thailand

Vorathep Sachdev, San Chaithiraphant

The Medical Facility Act B.E. 2541 (1998) (also known as the Sanatorium Act) was recently amended by the Medical Facility Act (No. 4) B.E. 2559 (2016) which introduced a number of changes to...

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November 30, 2010

Advertising in the Face of Food and Drug Administration Restrictions

In making a product stand out in a highly competitive market, business owners may be tempted to neglect legal restrictions on what they can claim about their product. Such marketing-driven...

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May 1, 2009

Advertising Materials: Process and Legal Concerns

In producing advertising material, skepticism can cause complications and a great deal of expense to your company. Due diligence on intellectual property and regulatory compliance of advertising...

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