Pharma Industry

Duong & Partners provides comprehensive advice on regulatory affairs and other legal aspects, requirements and conditions of doing business in pharmaceuticals in Vietnam with the following expertises:

• Conduct and provide patent search report to estimate the likelihood of infringement of patent rights (freedom-to-operate) which are being protected before starting a new pharmaceutical products in Vietnam;
• Advise and assist on registration, advertising and distribution of pharmaceuticals, cosmetics, food, food supplements at Ministry of Health of Vietnam;
• Advise and assist in Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), Good Laboratory Practice (GLP);
• Advise and assist in approval/ license and organization in conducting clinical trial studies, bio-availability and bio-equivalence studies for pharmaceutical products in Vietnam;
• Consult and assist to enter the list of innovator drugs, list of BA/BE testing, list of drugs equivalent with original proprietary drugs, list of PIC/S-GMP and EU-GMP;
• Advise and assist in participating in pharmaceutical bidding tenders, adding products into list of essential medicines or national insurance;
• Compliance legal due diligence to find out the problems, matters and advice, assistance in remedying the same in accordance with prevailing laws;
• Consult and assist to find strong distributors/manufacturers in Vietnam based on clients’ requirements;
• Any other regulatory matters during the operation of pharmaceutical businesses in Vietnam.