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

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
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Datesort icon Title
November 10, 2017

Asia Women in Business Law Awards 2017: Tilleke & Gibbins Wins Two Awards

Tilleke & Gibbins took home two trophies at the seventh annual Asia Women in Business Law Awards, being recognized as Firm of the Year for Vietnam as well as Best National Firm for Talent...

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October 10, 2017

Euromoney Asia Women in Business Law Awards 2017: Tilleke & Gibbins Nominated in Five Categories

Linh Thi Mai Nguyen

Tilleke & Gibbins has been nominated for awards in five categories in Euromoney Legal Media Group’s Asia Women in Business Law Awards 2017. The awards celebrate the advancement of women in the...

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October 2, 2017

Asialaw Awards 2017: Tilleke & Gibbins Nominated for Eight Regional Awards

Asialaw has released the shortlist of nominated firms for its first-ever Asialaw Awards, to be held on November 28 in Hong Kong. In the regional categories, which span 24 Asia-Pacific...

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October 2, 2017

Tilleke & Gibbins Shortlisted in Four Countries at Asialaw Awards

Tilleke & Gibbins has been recognized as a top firm in four Southeast Asian jurisdictions, landing on the shortlist for the following categories at the upcoming Asialaw Awards:

September 29, 2017

AMCHAM Thailand: Thai FDA Legal and Regulatory Update

Atthachai Homhuan, Siradapat Ratanakorn

Dr. Atthachai Homhuan, manager of Tilleke & Gibbins’ regulatory affairs group, and Siradapat Ratanakorn, a consultant in the group, will be discussing recent updates to Thai food product...

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Datesort icon Title
October 25, 2016

Effects of the TPP on Vietnam’s Pharmaceutical Industry

John Frangos, Chuyen Hong Huu Le

On February 4, 2016, Vietnam and 11 other countries signed the Trans-Pacific Partnership (TPP). The TPP includes Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, the...

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October 25, 2016

The Importance of Patents in Drug Tenders in Vietnam

Hien Thi Thu Vu

With a population of over 90 million, fast-paced economic growth, and an increasing standard of living, Vietnam has become a market with great potential for original brand name drugs. These drugs...

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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...

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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...

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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...

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