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 |
|
Areeya Pornwiriyangkura |
Associate | Bangkok |
+66 2653 5882 |
|
Atthachai Homhuan |
Regulatory Consultant | Bangkok |
+66 2653 5610 |
|
Darani Vachanavuttivong |
Partner | Bangkok |
+66 2653 5888 |
|
Dung Thi Kim Vu |
Patent Specialist | Hanoi |
+84 4 3772 5554 |
|
Jim Dao |
Consultant | Ho Chi Minh City |
+84 8 3936 2062 |
|
Kien Trung Trinh |
Associate | Hanoi |
+84 4 3772 5567 |
|
Michael K. Lee |
Partner | Ho Chi Minh City |
+84 8 3936 2069 |
|
Paul G. Russell |
Of Counsel | Bangkok |
+66 2653 5540 |
|
Pornsroung Saerekul |
Regulatory Consultant | Bangkok |
+66 2653 5606 |
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| Date | Title |
|---|---|
| April 22, 2011 |
Clemence Gautier to Speak on Clinical Trials On May 20, 2011, Clemence Gautier, Consultant, Intellectual Property, will speak at what has been billed as the most comprehensive forum on clinical trials in Thailand. Clinical Trial Forum... |
| February 1, 2011 |
PLC Which Lawyer Names the Firm’s IP Group a Leading Practice in Thailand Darani Vachanavuttivong, Alan Adcock In February of 2011, PLC Which Lawyer named the firm’s IP group a leading practice in Thailand, with the firm’s regulatory affairs practice, serving clients in the life sciences, also... |
| February 14, 2011 |
PLC Which Lawyer Endorses Tilleke & Gibbins Attorneys Alan Adcock, Darani Vachanavuttivong, Srila Thongklang, Sriwan Puapondh, Thawat Damsa-ard The Practical Law Company’s PLC Which Lawyer publication, regarded worldwide as the essential guide to lawyers and law firms in more than 110 countries, has endorsed the following Tilleke... |
| January 24, 2007 |
Thailand: Critical Need for New Investment This extensive feature covers a wide range of issues for Thailand’s pharmaceutical industry. Comments from Edward Madden and Edward Kelly of Tilleke & Gibbins are included in the feature. |
| February 2, 2007 |
Interview with Edward Kelly, Edward Madden, and Tiziana Sucharitkul Tiziana Sucharitkul This interview of Edward Kelly, Edward Madden, and Tiziana Sucharitkul covers a broad range of topics dealing with the overall intellectual property situation in Thailand, the impact of expected... |
| Date | Title |
|---|---|
| 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... |
| 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 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... |
| 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... |
| July 6, 2009 |
Outsourcing Product Registration in Asia – Why Expert Assistance Helps! Alan Adcock, Paul G. Russell As most ASEAN Food and Drug Administrations and Ministries of Agriculture labor under critical backlogs of product registration applications for the growing number of products being released into... |
