Life Sciences / Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 24 3772 5633
T: +84 24 3772 5606
T: +855 23 964 210
T: +6221 2971 8099
T: +66 2056 5871
T: +95 1 8255 208

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:
  • 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.

  • 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.

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July 14, 2020

Tilleke & Gibbins Highlighted in WTR Article on Diversity and Inclusion in Asian Law Firms

In a research project to celebrate Pride Month 2020, World Trademark Review  (WTR) recently set out to explore the landscape of diversity and inclusion initiatives in...

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July 3, 2020

Asialaw Awards 2020: Tilleke & Gibbins Nominated for Three National Firm of the Year Awards

Tilleke & Gibbins has been nominated for three Firm of the Year Awards at the third Asialaw Regional Awards—an Asia-wide awards ceremony recognizing the best law firms across the region. The...

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June 10, 2020

Atthachai Homhuan to Lead Video Conference on Regulations for Thailand’s Cannabis Industry

Atthachai Homhuan

On June 19, 2020, Dr. Attachai Homhuan, manager of Tilleke & Gibbins’ regulatory affairs...

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June 5, 2020

Yuwadee Thean-ngarm and Nada Songsasen to Join TBAM’s Myanmar Update #6: COVID-19

Nada Songsasen, Yuwadee Thean-ngarm

On June 10, Yuwadee Thean-ngarm, director of Tilleke & Gibbins’ Yangon office and secretary-general of the Thai...

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May 28, 2020

Tilleke & Gibbins Named Visionary Client Service Law Firm of the Year

Tilleke & Gibbins is proud to have been named Visionary Client Service Law Firm of the Year – Asia at the 2020 Counsels of the Year Awards, hosted by the Asian-Mena Counsel  ...

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June 25, 2020

Practical Law: Agricultural Law in Thailand 2020

Chaiwat Keratisuthisathorn, Chanchai Jhongsathit, Michael Ramirez, Salil Siriwat, Siradapat Ratanakorn, Varapa Aurat

Practical Law has published an updated online version of Agricultural Law in Thailand, a Q&A-style guide that provides detailed overviews of the law affecting...

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June 15, 2020

Thailand Takes Steps to Ensure Availability of High-Demand Medical Supplies

Tayagorn Warathornthnakul, Kittiya Nopparatrungroj

Dealing with the COVID-19 pandemic has taken top priority for almost every country in the world. In Thailand, even though the strength of the country’s health security measures has been ranked...

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May 13, 2020

Tilleke & Gibbins Cannabis and Hemp Business Guide – Thailand

Alan Adcock, Atthachai Homhuan, San Chaithiraphant

Attorneys in Tilleke & Gibbins’ regulatory affairs team have produced the Cannabis and Hemp Business Guide – Thailand, a primer on the rapidly developing cannabis industry...

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May 5, 2020

Lex Mundi Global Attorney-Client Privilege Guide – Thailand Chapter

Michael Ramirez

The Global Attorney-Client Privilege Guide, published by Lex Mundi, provides information on what constitutes attorney-client privilege in over 65 jurisdictions around the world. The Thailand...

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April 20, 2020

Myanmar Announces Factory Inspections, Assembly Restrictions, and Curfew

Nada Songsasen, Nwe Oo, Yuwadee Thean-ngarm

On April 19, 2020, Myanmar’s Ministry of Labour, Immigration and Population announced a nationwide inspection of factories and workshops from April 20 to 30 to ensure...

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