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.

  •   
  • Page :
  • 1
  • 2
  • 3
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

San Chaithiraphant

T:+66 2056 5640

E-mail

Associate
Bangkok

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
  •   
  • Page :
  • 1
  • 2
  • 3
Datesort icon Title
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...

Read more

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 “...

Read more

November 30, 2017

Tilleke & Gibbins Among Top Firms in Cambodia in Legal 500 Asia Pacific 2018

In its first survey of the Cambodian legal market, The Legal 500  has awarded Tilleke & Gibbins a Tier 2 ranking, placing it in the top six firms in the country.

The...

Read more

November 30, 2017

Legal 500 Lauds Tilleke & Gibbins with a Tier 1 Ranking in Laos

The Legal 500 Asia Pacific  has ranked Tilleke & Gibbins as a Tier 1 Leading Firm in Laos—a status only awarded to one other law firm in the country.

The Legal 500...

Read more

November 29, 2017

Tilleke & Gibbins Wins Three Asialaw Firm of the Year Awards

Tilleke & Gibbins has received high accolades for its exceptional regional practice at the inaugural Asialaw Asia-Pacific Legal Practice Awards, where it was named Southeast Asia Firm of the...

Read more

Datesort icon Title
February 6, 2017

PLC Doing Business in … Global Guide 2017 – Vietnam Chapter

Attorneys from Tilleke & Gibbins have written the Vietnam chapter of Practical Law Company’s Doing Business in … Global Guide, an essential handbook for businesses looking to expand...

Read more

January 24, 2017

PLC Doing Business in … Global Guide 2017 – Thailand Chapter

Michael Ramirez, Kasma Visitkitjakarn, Sriwan Puapondh, Darani Vachanavuttivong

The 2017 edition of Doing Business In…, a Q&A-style guide published by Practical Law Company in collaboration with Lex Mundi, presents an overview of...

Read more

January 23, 2017

2016 Pharmaceutical Patent Overview for Vietnam

Thomas J. Treutler, Thang Duc Nguyen, 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...

Read more

January 9, 2017

Vietnam: Imported Medical Devices Will Require Registration in 2017

Hien Thi Thu Vu

Starting in 2017, all medical devices imported into Vietnam will be required to register for marketing authorization (MA) licenses. Previously, imported medical devices did not require MA licenses...

Read more

November 25, 2016

Intellectual Property Linkage: Connecting IP Offices with Regulators

Alan Adcock

Intellectual property (IP) linkage refers to connecting an IP office, through open communication lines and complementary processes, to other government agencies that work on IP. This generally...

Read more