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Regulatory Affairs

Regulatory Affairs

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

OVERVIEW

Specialized support from experts who know your industry.

Our dynamic regulatory affairs 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.

We assist with the registration and prosecution of pharmaceuticals, biotechnology 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.

Our practice spans the following disciplines:

  • Clinical trials and consumer testing
  • Registration with public health authorities
  • FDA import, export, and manufacturing licenses
  • Crop care registration with agricultural regulatory authorities
  • Animal, aquatic, and hazardous substance registration
  • Import, export, and manufacturing licenses
  • Holding licenses
  • Regulatory compliance and maintenance
  • Labeling and advertising clearance
  • Intellectual property
Case Studies

Experience

  • 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.
  • Represented a world-leading pharmaceutical company on regulatory due diligence in their spin-off of high revenue product lines (i.e., over-the-counter antihistamines, cough relief syrups, tablets and elixirs) to another major pharmaceutical company.
  • Retained to advise an American biotechnology manufacturing company on Southeast Asian drug approval for several of their bespoke personal care and pharmaceutical products.
  • Acted for a Canadian standards and regulatory consultancy firm in conducting a regulatory landscape project on anti-microbial processing aids for the food industry in four jurisdictions in Southeast Asia. Our Regulatory Affairs teams across our offices advised the client on applicable government agencies, regulations, regulatory submissions, and other requirements for their product. The invaluable information we provided prompted the client to retain our teams for a subsequent regulatory landscape project on nutraceuticals.
  • Assisted a European medical device and pharmaceutical company active in over 50 countries to successfully obtain VIPRI (Vietnam Intellectual Property Research Institute) opinions that two foreign-produced products imported into Vietnam were infringing.
  • Assisted a global pharmaceutical company, with registration of and regulatory approval for its drugs with the Myanmar Food and Drug Administration (FDA), while simultaneously working to stem the flow of counterfeit drugs that were being sold in the Myanmar market.
  • Acted as lead Thai counsel to a major pharmaceutical company on various regulatory affair matters including, 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.
  • Seconded a lawyer to the Vietnam subsidiary of a U.S.-based global medical devices and consumer products company to fill their in-house counsel position. Our secondee was in charge of legal matters for all of the client’s subsidiaries and representative offices in Vietnam in relation to their pharmaceuticals, consumer goods, and medical devices operations
  • 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.
  • Assisted a multinational confectionery company with registration of various chocolate and mint products in Thailand and Vietnam, and provided advice on food labeling requirements, classification of food products, food additive regulations, and parallel import of foods.

PROFESSIONALS

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