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 |
|---|---|
| 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... |
| December 21, 2012 |
Chambers Asia Pacific Awards 2013: Tilleke & Gibbins Shortlisted for Thailand Law Firm of the Year Darani Vachanavuttivong, Tiziana Sucharitkul Recognizing the firm’s status in the upper echelon of the Thai legal market, Chambers and Partners has nominated Tilleke & Gibbins for its Thailand Law Firm of the Year award. The firm is one... |
|
Date |
Title |
|---|---|
| July 6, 2009 |
Combating Generics: Rising Pharmaceutical Patent Litigation Trend Siraprapha Rungpry In recent years, Thailand has seen an increasing number of pharmaceutical patent litigations, launched by drug originators to combat infringing generic products in the market. This article looks... |
| June 6, 2009 |
Product Labels Are More than Just Stickers Recent scandals, particularly the one involving melamine-tainted milk from China, have impacted consumer awareness in a big way, making consumers pay more attention to the quality and safety of... |
| May 18, 2009 |
IP Laws and Product Approvals in ASEAN Areeya Pornwiriyangkura Recently, the members of Association of Southeast Asian Nations (ASEAN) attempted to improve product registration efficiency and marketing approval for pharmaceutical products. The ASEAN... |
| May 11, 2009 |
David Lyman Within the past two years, Thailand has experienced a number of events that have called into question the country’s political stability. In this article, David Lyman reflects on the situation and... |
| May 1, 2009 |
Advertising Materials: Process and Legal Concerns Areeya Pornwiriyangkura In producing advertising material, skepticism can cause complications and a great deal of expense to your company. Due diligence on intellectual property and regulatory compliance of advertising... |
