Praween Chantanakomes
Head of Regulatory Affairs Services Department | Senior Associate
Praween joined Baker McKenzie in 2008. He is currently active in the Corporate and M&A, regulatory and compliance practice areas, with a specialization on the Healthcare & Life Sciences Industry. Praween has been heavily involved in the industry-related advice and anti-bribery compliance area. His areas of focus also include investigations and internal audits for compliance purposes. Praween is one of our leading members of the Compliance & Investigation team in Asia Pacific. He has been advising a few major associations of manufacturers and importers of healthcare-related products.
Prim Uditananda
Regulatory Affairs Manager
Prior to joining Baker McKenzie in 2011, Prim worked at a regulatory affairs consultant company and handled various FDA- related issues and applications. With over 25 years of experience, Prim has gained an expertise in providing professional consultation in regulatory affairs, manufacturing registration, and product registration with the Thai Food and Drug Administration (“FDA”), and other related fields, such as the Department of Medical Science, the Department of Livestock Development, the Thai Industrial Standard Institute, and the Department of Industrial Works. Her focus is in the areas of pharmaceutical and biologic product, herbal product, food, medical device, cosmetic, hazardous substance and advertisement review and approval.
Prim has been advising a wide range of manufacturers and importers on the requirements and duties of the license-holder, how to prepare importers’ offices and warehouses according to relevant regulations, and planning and control of project timeframes. She also provides FDA compliance consultancy services, specializing in food manufacturing, medical device manufacturing, and cosmetics manufacturing, including assisting manufacturers in setting up a manufacturing facility and obtaining a manufacturing license. She is experienced in giving preliminary reviews and opinions on product classification and providing consultation on the product registration process, timeline, associated costs and related issues.