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.
Regulatory Affairs
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:
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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.
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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.
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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.
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Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
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Secured an export license for the client in an efficient manner, as required by the head of the product group.
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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.
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Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
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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.
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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.
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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.
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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 | Contact |
|---|---|---|---|
|
Alan Adcock |
Partner | Bangkok |
+66 2653 5871 |
|
Darani Vachanavuttivong |
Partner | Bangkok |
+66 2653 5888 |
|
Michael K. Lee |
Partner | Ho Chi Minh City |
+84 8 3936 2069 |
|
Paul G. Russell |
Of Counsel | Bangkok |
+66 2653 5540 |
|
Areeya Pornwiriyangkura |
Associate | Bangkok |
+66 2653 5882 |
|
Kien Trung Trinh |
Associate | Hanoi |
+84 4 3772 5567 |
|
Tu Ngoc Trinh |
Associate | Hanoi |
+84 4 3772 5556 |
|
Jim Dao |
Consultant | Ho Chi Minh City |
+84 8 3936 2062 |
|
Siraprapha Rungpry |
Consultant | Bangkok |
+66 2653 5874 |
|
Dung Thi Kim Vu |
Patent Specialist | Hanoi |
+84 4 3772 5554 |
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Date |
Title |
|---|---|
| June 19, 2013 |
Asian Legal Business: Tilleke & Gibbins Voted Employer of Choice 2013 in Thailand and Vietnam Darani Vachanavuttivong, Tiziana Sucharitkul Tilleke & Gibbins is one of the best employers in the legal marketplace in Thailand and Vietnam, according to a recent survey of legal professionals across Asia. In its June 2013 cover story... |
| May 9, 2013 |
Suebsiri Taweepon to Speak at Personal Care Summit on Counterfeit Products and Threats to the Market Suebsiri Taweepon This Personal Care Summit conference will provide attendees with a complete and contemporary overview of the current personal care market, including cosmetics, skincare, and haircare. The... |
| April 12, 2013 |
Asian Legal Business: Tilleke Adds U.S. Attorney in HCMC Jim Dao Industry publication Asian Legal Business is reporting on the hiring of American lawyer Jim Dao by Tilleke & Gibbins. Joining the firm’s Ho Chi Minh City office, Jim is an experienced... |
| April 3, 2013 |
Tilleke & Gibbins Life Sciences Partners Recognized by Law Business Research Srila Thongklang, Thomas J. Treutler Law Business Research, a legal publisher that serves as the official research partner of the International Bar Association, has recognized two Tilleke & Gibbins partners for their expertise in... |
| January 8, 2013 |
Tilleke & Gibbins Promotes Four to Partnership in Bangkok Charunun Sathitsuksomboon, Kobkit Thienpreecha, Chusert Supasitthumrong, Sukontip Jitmongkolthong Leading Southeast Asian regional law firm Tilleke & Gibbins has promoted four attorneys to the firm’s partnership, effective January 2013. Coming from across the major practice groups... |
|
Date |
Title |
|---|---|
| May 7, 2013 |
PLC Life Sciences Multi-Jurisdictional Guide 2013 – Thailand Chapter Alan Adcock, Areeya Pornwiriyangkura In recent years, the Thai FDA has made large-scale efforts to tighten its budget and escalate its standards of scrutiny. In response to these changes, this article provides insight into the... |
| May 7, 2013 |
PLC Life Sciences Multi-Jurisdictional Guide 2013 – Vietnam Chapter Tu Ngoc Trinh This Q&A chapter analyzes legal issues pertaining to Vietnam’s regulatory framework in the life sciences industry. Ranging from the quality of national healthcare, manufacturing authorization... |
| March 20, 2013 |
Lex Mundi Guide to Doing Business in Thailand 2013 Published by Tilleke & Gibbins in association with Lex Mundi, the Guide to Doing Business in Thailand provides a comprehensive overview of the legal environment for investors entering... |
| February 26, 2013 |
Online Pharmacies in Thailand: Potential Risks Atthachai Homhuan “Save 30% if you buy today!” This is just one of many familiar e-commerce advertisements that regularly bombard consumers online. By employing many of the same techniques that have proven to be... |
| February 20, 2013 |
Local Distributor Partnerships: Investigate Before You Terminate Alan Adcock Foreign companies usually opt to appoint their local distributors as the local entity to apply for and maintain product registration and import licenses, as usually required by Asian FDAs and... |
