Pharmaceuticals

Advice on regulations, rules, provisions, conditions with regard to production, sales, import, and export of pharmaceutical products in Vietnam.
Advice and assistance in participating in pharmaceutical bidding tenders, and adding products into the list of essential medicines or national insurance.
Advice and assistance in obtaining approvals/ licenses and organization in conducting clinical trial studies, bio-availability and bio-equivalence studies for pharmaceutical products in Vietnam.
Advice and assistance in the preparation of application dossiers then follow-up of the evaluation process for the purpose of getting licenses and approvals from the Drug Administration of Vietnam with regard to the registration of new products, renewals, changes and variations.
Translation and conversion of documents with a focus on preparing label artwork, pack inserts, and product information leaflets in Vietnamese in conformity with the legal regulations of Vietnam.
Advice and assistance in pharmaceutical post marketing surveillance, pharmacovigillance as well as adverse reaction reports (ADR), product quality test, and other areas.
Advice and assistance in all regulatory matters in Vietnam.

Advice on conditions, requirements and procedures applicable to advertisement and/or promotion programs in the pharmaceutical industry.
Advice and assistance in preparing application dossiers to obtain permits for advertising, promotion programs and campaigns for pharmaceutical products.
Submission and obtainment of approvals/ licenses for advertising, product information and promotion programs.
Advice on product labelling in order to be in compliance with Vietnamese law.
Other relevant matters.

Comprehensive advice on regulatory affairs and other legal aspects, requirements and conditions of doing business in pharmaceuticals including import & export, manufacture and sales, medical representatives, free-of-charge products, custom clearance, safety surveillance and reports.
Legal advice on competition, intellectual property, counterfeit and infringing products, patented and off-patent products.
Advice and assistance in Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), and Standard Operation Procedures, (SOP).
Compliance legal due diligence to find out any problems, matters and advice, and assistance in remedying the same in accordance with Vietnamese law.
Advice, assistance and representation in handling complaints, adverse reactions and side effects, insurance claims relating to use of medicines, drugs, and pharmaceutical preparations.
Advice and assistance with all other regulatory matters during the operation of your pharmaceutical businesses in Vietnam.

PHARMACEUTICALS