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 |
|---|---|---|---|
|
Paul G. Russell |
Of Counsel | Bangkok |
+66 2653 5540 |
|
Pornsroung Saerekul |
Regulatory Consultant | Bangkok |
+66 2653 5606 |
|
Atthachai Homhuan |
Regulatory Consultant | Bangkok |
+66 2653 5610 |
|
Siradapat Ratanakorn |
Regulatory Consultant | Bangkok |
+66 2653 5622 |
|
Salil Siriwat |
Patent Specialist | Bangkok |
+66 2653 5670 |
|
Alan Adcock |
Partner | Bangkok |
+66 2653 5871 |
|
Siraprapha Rungpry |
Consultant | Bangkok |
+66 2653 5874 |
|
Areeya Pornwiriyangkura |
Associate | Bangkok |
+66 2653 5882 |
|
Darani Vachanavuttivong |
Partner | Bangkok |
+66 2653 5888 |
|
Dung Thi Kim Vu |
Patent Specialist | Hanoi |
+84 4 3772 5554 |
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| Date | Title |
|---|---|
| November 13, 2009 |
Thailand Joins Forces with WHO, Interpol Task Force to Fight Invasion of Counterfeit Drugs Thailand's pharmaceutical industry is helping inform the citizenry about the dangers of counterfeit medicines as the country joins forces with groups including Interpol, the World Health... |
| 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 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... |
| June 21, 2011 |
The BigChilli Magazine Interviews David Lyman David Lyman The BigChilli, a Bangkok-based lifestyle magazine, recently interviewed David Lyman, Chairman & Chief Values Officer of Tilleke & Gibbins. The interview highlighted the background... |
| June 27, 2011 |
Oxford Business Group Launches The Report: Thailand 2011 David Lyman In the wake of 2010’s political unrest and with upcoming national elections on the horizon, the climate for business and foreign direct investment in Thailand remains uncertain. The Report:... |
| Date | Title |
|---|---|
| August 5, 2009 |
Market Insight – Clarity Needed Over ASEAN Regulators’ Position Alan Adcock The variety and ever-changing nature of regulations governing patent and drug approvals across the Asian region, along with policies which often favor local generics, can pose a daunting challenge... |
| July 15, 2009 |
Siraprapha Rungpry Generic drug manufacturers in Thailand have become particularly active in recent years. There is a clear development trend among local generic producers to catch up with new technology and take... |
| 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... |
| May 11, 2011 |
The Report: Thailand 2011 – Legal Framework The Report: Thailand 2011, published by Oxford Business Group, provides an in-depth analysis of various sectors of the Thai economy. In the legal section of the publication, Tilleke... |
| May 3, 2011 |
Viewpoint – The Political Scene in Thailand: Pre-Election Observations David Lyman In response to regular queries received from our multinational clients, David Lyman, Chairman & Chief Values Officer of Tilleke & Gibbins, has been providing periodic updates on the... |
