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 |
|---|---|
| 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... |
| March 17, 2011 |
David Lyman David Lyman, Chairman & Chief Values Officer of Tilleke & Gibbins, was recently invited to participate in the inaugural BRT Business Leaders Lunch. Held at the JW Marriott in Bangkok, the... |
| 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... |
| 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... |
| 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... |
| Date |
Title |
|---|---|
| September 21, 2008 |
Pharmaceutical Industry in Asia Alan Adcock, Siraprapha Rungpry The development of the pharmaceutical industry in Asia has been influenced by government policies and the growth in the laws and regulatory bodies that oversee various aspects of drug manufacture... |
| May 21, 2012 |
Pharmaceutical Product Recall: New FDA Requirements Atthachai Homhuan Medicine is an integral part of our lives, helping us to recover from illness and allowing us to live a longer and healthier life. However, the great benefits derived from medicine are also... |
| March 9, 2010 |
PLC Cross-border Doing Business in … Handbook 2010 – Thailand Chapter Chinachart Vatanasuchart, Kobkit Thienpreecha, Siraprapha Rungpry, Sriwan Puapondh This chapter provides an overview of the legal system and key laws for foreign companies doing business in Thailand. Presented in a question-and-answer format, the chapter examines the rules... |
| March 11, 2011 |
PLC Cross-border Doing Business in … Handbook 2011 – Thailand Chapter Pimvimol (June) Vipamaneerut, Siriwan Phentalay, Chaiwat Keratisuthisathorn, Charunun Sathitsuksomboon, Hiranrat Chakartnarodom This chapter provides an overview of the legal system and key laws for foreign companies doing business in Thailand. Presented in a question-and-answer format, the chapter examines the rules... |
| December 23, 2011 |
PLC Doing Business in … Multi-Jurisdictional Guide 2012 – Thailand Chapter Sriwan Puapondh, Hiranrat Chakartnarodom, David Duncan, Chaiwat Keratisuthisathorn, Michael Ramirez, Anake Rattanajitbanjong This chapter provides an overview of the legal system and key laws for foreign companies doing business in Thailand. Presented in a question-and-answer format, the chapter examines the rules... |
