- 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.