Regulatory Affairs

Featured Publication: PLC Life Sciences
Contacts
T: +66 2653 5871
T: +66 2653 5610
T: +84 8 3936 2069
T: +6221 2971 8099
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.

  •   
  • Page :
  • 1
  • 2
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
  •   
  • Page :
  • 1
  • 2
Datesort icon Title
May 29, 2012

Seminar for Healthcare Companies: Preparing for the ASEAN Economic Community

Somboon Earterasarun, Areeya Pornwiriyangkura

The ASEAN Economic Community (AEC), which will come into effect in 2015, will integrate the region’s economies and create a single market of 600 million consumers. All industries are bracing for...

Read more

April 26, 2012

Law Business Research Recognizes Three Tilleke & Gibbins Life Sciences Practitioners

Srila Thongklang, Thomas J. Treutler

Three members of the Tilleke & Gibbins team have been named to The International Who’s Who of Life Sciences Lawyers 2012. Published by Law Business Research, the official research...

Read more

March 21, 2012

Tilleke & Gibbins Rated as Leading Life Sciences Firm in Thailand by PLC Which Lawyer

Practical Law Company, a well-recognized provider of legal market intelligence and analysis, has ranked Tilleke & Gibbins as a “Leading” Life Sciences firm in Thailand in the most recent...

Read more

February 1, 2012

Tilleke & Gibbins Elevates Michael K. Lee to Partner

Michael K. Lee

Tilleke & Gibbins is proud to announce the appointment of Michael K. Lee as a Partner of the firm, effective January 1, 2012.

Michael counsels clients and manages cases on a wide range...

Read more

December 28, 2011

Oxford Business Group and Tilleke & Gibbins Seal Third Partnership for 2012 Publication

Tiziana Sucharitkul

Oxford Business Group (OBG), the global publishing, research and consultancy company, has renewed its partnership with Tilleke & Gibbins for its latest report on Thailand’s economy.

As...

Read more

Datesort icon Title
August 29, 2014

Food Labeling: A Recent Change in the Thai Paradigm

Ruchanikorn Makayay, Siradapat Ratanakorn

In response to consumers paying more attention to their dietary nutritional values, the food industry has taken steps to alter its approach to food product labeling. Labels that stipulate nutrient...

Read more

August 28, 2014

Good Manufacturing Practices in Thailand

Pornsroung Saerekul

In Thailand, Good Manufacturing Practices (GMP) were first implemented in 1979 for local pharmaceutical manufacturers under the Drug Act 1967 (B.E. 2510). In 1984, the Thai Food and Drug...

Read more

July 8, 2014

Thai FDA Introduces Fast-Track Procedure for Food Registration

Ruchanikorn Makayay, Siradapat Ratanakorn

The Thai Food and Drug Administration (Thai FDA) has recently amended its food product registration and controlling procedures to shorten its approval timelines, without compromising food quality...

Read more

July 3, 2014

The International Comparative Legal Guide to: Pharmaceutical Advertising 2014 – Vietnam Chapter

Tu Ngoc Trinh, Tu Thanh Pham

Life sciences experts Tu Ngoc Trinh and Tu Thanh Pham of the Tilleke & Gibbins corporate and commercial team in Hanoi have co-authored the Vietnam chapter of The International Comparative...

Read more

May 5, 2014

Vietnam Pharma Update 2014

While Vietnam represents a huge potential market for foreign investors in the pharmaceutical industry, the sector is heavily regulated and clear guidelines are not always available. To guide...

Read more