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 |
|---|---|---|---|
|
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 |
|
Siraprapha Rungpry |
Consultant | Bangkok |
+66 2653 5874 |
|
Jim Dao |
Consultant | Ho Chi Minh City |
+84 8 3936 2062 |
|
Paul G. Russell |
Of Counsel | Bangkok |
+66 2653 5540 |
|
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 |
|
Dung Thi Kim Vu |
Patent Specialist | Hanoi |
+84 4 3772 5554 |
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| Date |
Title |
|---|---|
| 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... |
| October 12, 2012 |
Euromoney Asia Women in Business Law Awards: Tilleke & Gibbins Shortlisted in Four Categories Darani Vachanavuttivong, Tiziana Sucharitkul On November 22, 2012, the Euromoney Legal Media Group will hold its second annual Asia Women in Business Law Awards at the Renaissance Harbour View Hotel in Hong Kong. Again this year,... |
| December 17, 2010 |
Interview with Cynthia M. Pornavalai on Legal Reform Cynthia M. Pornavalai In this interview with Business Report Thailand, Tilleke & Gibbins partner Cynthia M. Pornavalai discusses the possibility of government reform to boost investment. Cynthia examines... |
| 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... |
| April 26, 2012 |
Law Business Research Recognizes Three Tilleke & Gibbins Life Sciences Practitioners Srila Thongklang, Thomas J. Treutler Three members of the Tilleke & Gibbins team have been named to The International Who’s Who of Life Sciences Lawyers 2012. Published by Law Business Research, the official research... |
| Date |
Title |
|---|---|
| June 4, 2007 |
Michael Ramirez Recently the Thai government has expressed its intent to enforce a total ban on alcohol advertising in the Kingdom. The ban, which was originally introduced by the Thai Food and Drug... |
| November 30, 2010 |
Advertising in the Face of Food and Drug Administration Restrictions Areeya Pornwiriyangkura In making a product stand out in a highly competitive market, business owners may be tempted to neglect legal restrictions on what they can claim about their product. Such marketing-driven... |
| 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... |
| April 16, 2009 |
Bangkok Report – The Songkran (Thai New Year) Skirmish of 2009 David Lyman This open letter from David Lyman to the clients of Tilleke & Gibbins addresses the events that unfolded in April 2009, when political demonstrations—sometimes violent—took place in Bangkok... |
| May 6, 2011 |
Beating Cosmetic Product Registration Hurdles On January 1, 2008, Asean member countries implemented the Asean Harmonization Cosmetics Regulation Scheme in order to harmonize a previously chaotic process. A multitude of confusing laws and... |
