Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2653 5871
T: +66 2653 5610
T: +84 8 3936 2069
T: +6221 2971 8099
T: +66 2653 5505
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 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
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Datesort icon Title
September 5, 2012

Client Alert: New Requirements for First-Time Overseas Pharmaceutical Manufacturers

Alan Adcock

Starting October 1, 2012, overseas pharmaceutical manufacturers that have never before been recorded in the Drug Product Registry of Thailand will need to be accredited by the Thai Food and Drug...

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September 4, 2012

Tilleke & Gibbins and NIA to Hold IP Lunch Talk on Medical Devices

On September 21, 2012, Tilleke & Gibbins, together with the National Innovation Agency, will host a Thai-language seminar on “Medical Devices: Opportunities & Regulations.” The seminar...

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June 18, 2012

Clinical Trial Forum 2012 to Feature Tilleke & Gibbins Pharmaceutical Expert

Atthachai Homhuan

On June 28, 2012, Dr. Atthachai Homhuan, senior consultant in the Tilleke & Gibbins intellectual property and regulatory affairs groups, will be presenting at the 3rd Annual Clinical Trial...

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May 29, 2012

Tilleke & Gibbins Partners Discuss the Thai Pharmaceutical Industry

Darani Vachanavuttivong, Tiziana Sucharitkul, Alan Adcock

The Thai pharmaceutical industry is characterized by its expanding yet challenging landscape. Amidst growing medical tourism and strong R&D centers in the Asia Pacific region, issues related...

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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...

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Datesort icon Title
January 7, 2015

Lex Mundi Guide to Doing Business in Thailand 2015

Tilleke & Gibbins, in association with Lex Mundi, has published the latest edition of the Guide to Doing Business in Thailand. The guide provides a comprehensive overview of the legal...

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December 22, 2014

PLC Doing Business In … Multi-Jurisdictional Guide 2015 – Thailand Chapter

Darani Vachanavuttivong, Sriwan Puapondh, Kitti Thaisomboon, Michael Ramirez, Areeya Pornwiriyangkura, Anake Rattanajitbanjong, Passanan Suwannoi, Kasma Visitkitjakarn, Ahmet Yesilkaya, Penrurk Phetmani

Practical Law Company, in association with Lex Mundi, has published the latest edition of its Q&A guides to doing business worldwide. The Thailand chapter, authored by Tilleke & Gibbins...

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December 22, 2014

PLC Doing Business In … Multi-Jurisdictional Guide 2015 – Myanmar Chapter

Michael Ramirez, Nwe Oo, Shalini Ghosh

In association with Lex Mundi, Practical Law Company has published the latest edition in its series of Q&A-style guides to doing business in jurisdictions around the world. The Myanmar chapter...

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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...

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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...

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