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:
-
-
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.
-
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.
-
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.
-
Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
-
Secured an export license for the client in an efficient manner, as required by the head of the product group.
-
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.
-
Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
-
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.
-
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.
-
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.
-
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.
- Page :
- 1
- 2
| Name |
Position |
Office | Contact |
|---|---|---|---|
|
Salil Siriwat |
Patent Specialist | Bangkok |
+66 2653 5670 |
|
Siradapat Ratanakorn |
Regulatory Consultant | Bangkok |
+66 2653 5622 |
|
Atthachai Homhuan |
Regulatory Consultant | Bangkok |
+66 2653 5610 |
|
Trang Thu Ngo |
Regulatory Consultant | Hanoi |
+84 4 3772 6688 |
|
Pornsroung Saerekul |
Regulatory Consultant | Bangkok |
+66 2653 5606 |
- Page :
- 1
- 2
| 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 |
|---|---|
| July 6, 2009 |
Paul G. Russell Recent years have witnessed a proliferation in the number of products available under the “nutritional food” heading. For companies to stand out from their competitors in this growing sector,... |
| February 28, 2011 |
Client Q&A: Product Registration at the Thai FDA and MOA Alan Adcock The Thai Food and Drug Administration (FDA) and the Ministry of Agriculture (MOA) are considered among the most stringent regulatory agencies in Asia. Alan Adcock and Clemence Gautier of the... |
| 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... |
| 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... |
| September 17, 2009 |
Competitiveness of the Thai Healthcare Industry Paul G. Russell In the last decade, Thailand has established the objective of becoming a regional player in the pharmaceutical industry. In 2004, the Thai government adopted a five-year plan to develop the... |
