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Life Sciences

Life Sciences

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

OVERVIEW

Our unified teams of legal and scientific professionals across Southeast Asia offer unparalleled expertise in the life sciences.

The Tilleke & Gibbins life sciences team combines experienced commercial attorneys, patent experts with technical degrees, and licensed pharmacists with industry experience to offer a full range of services to companies operating in pharmaceuticals, cosmetics, food and beverages, biotechnology, medical devices, veterinary products, consumer products, and other life sciences sectors. We stand ready to assist you with:

  • Regulatory Affairs. Registration and prosecution of pharmaceuticals, biotech products, food and food supplements, narcotic and psychotropic substances, medical devices, cosmetics, hazardous substances, and animal and crop health products with national food and drug agencies and agricultural regulators.
  • Corporate and Transactional. Advising on corporate establishment, cross-border and multi-jurisdictional transactions, labor and employment, due diligence, compliance investigations, IP valuation and licensing, assignments and acquisitions, franchising, distributorship, technology transfer, and tax and customs issues.
  • IP Registration. Strategic portfolio management of patents, trademarks, trade secrets, copyright, and geographical indications, including IP search, registration, freedom-to-operate opinions, recordal, and prosecution.
  • IP Enforcement and Litigation. Advising on pre-litigation and arbitration, IP litigation and strategy, validity challenges and invalidations, product liability, consumer complaints and recalls, and monitoring for infringing products in the market or under the application process.

Experience

  • Acted as counsel to a major pharmaceutical company by 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.

PROFESSIONALS

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