Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 8 3936 2069
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

Michael K. Lee

T:+84 8 3936 2069

E-mail

Partner
Ho Chi Minh City

Chuyen Hong Huu Le

T:+84 8 3936 2079

E-mail

Associate
Ho Chi Minh City

Kien Trung Trinh

T:+84 4 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

Tu Ngoc Trinh

T:+84 4 3772 5556

E-mail

Associate
Hanoi

Cuong Hong Dang

T:+84 4 3772 8811 ext. 107

E-mail

Consultant
Hanoi

David Mol

T:+855 23 964 210

E-mail

Consultant
Phnom Penh
  •   
  • Page :
  • 1
  • 2
  • 3
Datesort icon Title
February 1, 2017

Chambers Asia-Pacific Awards 2017: Tilleke & Gibbins Top Contender for Thailand Law Firm of the Year Award

Darani Vachanavuttivong, Tiziana Sucharitkul

Tilleke & Gibbins has been nominated for the Thailand Law Firm of the Year Award 2017 by Chambers Asia-Pacific. The firm has been nominated for the award six times since 2010, and was...

Read more

January 19, 2017

Tilleke & Gibbins Earns Spot in First-Ever “Emerging Markets Experts” List by Asian Legal Business

Tiziana Sucharitkul, Darani Vachanavuttivong

Asian Legal Business (ALB)  has published an “Emerging Markets Experts” list for the first time, with Tilleke & Gibbins among 11 firms across Asia named to the list.

...

Read more

November 17, 2016

Asian-Mena Counsel: Tilleke & Gibbins Named Firm of the Year for IP (Thailand) and Life Sciences (Vietnam)

Darani Vachanavuttivong, Thomas J. Treutler

Asian-Mena Counsel  magazine has named Tilleke & Gibbins as Thailand Firm of the Year in Intellectual Property and Vietnam Firm of the Year in Life Sciences in its In-House...

Read more

November 14, 2016

Euromoney Asia Women in Business Law Awards 2016: Tilleke & Gibbins Named Thailand Firm of the Year

Tiziana Sucharitkul, Darani Vachanavuttivong

Tilleke & Gibbins has been named Thailand Firm of the Year at the Euromoney Legal Media Group Asia Women in Business Law Awards 2016. The awards ceremony was held on November 9 at the JW...

Read more

November 4, 2016

Siradapat Ratanakorn Featured in Just-Food Article on Packaged Food in Thailand

Siradapat Ratanakorn

Siradapat Ratanakorn, a food technologist and a consultant in Tilleke & Gibbins’ regulatory affairs group, was featured in an article titled “Packaged Food in Thailand – Impulse and Health to...

Read more

Datesort icon Title
October 3, 2016

Biosimilars in Thailand

Alan Adcock, Atthachai Homhuan

In 2002, the Thai government initiated a universal healthcare scheme to bring equitable healthcare access to the general public. Under the scheme, hospitals receive per capita funding based on 47...

Read more

October 3, 2016

Data Exclusivity for Biologics in Vietnam: Present and Future Regulations

Hien Thi Thu Vu

Biologics are composed of complex, large molecules, as opposed to the small molecules that make up conventional chemically derived drugs. Because of the complex nature of biologics, clinical...

Read more

August 30, 2016

Nutrition Claims in Thailand

“Let food be your medicine" is a common mantra recited by those in the food business. In Thailand, many food products are fortified with nutrients such as vitamins, minerals and amino acids, and...

Read more

August 26, 2016

Vietnam’s New Pharmaceutical Law

Chuyen Hong Huu Le, Kien Trung Trinh

The National Assembly of Vietnam adopted a new Law on Pharmacy on June 4, 2016. The new law will take effect on January 1, 2017, replacing the current version which was passed in 2005. In an...

Read more

August 26, 2016

Product Labeling in Laos: New Regulations Require Local Language on Packaging

Dino Santaniello

The Lao government has recently stepped up its efforts to raise public awareness of health issues and the quality of products sold in the market. The impetus behind the government’s actions is...

Read more