SEN Pharma provides consultation in the following aspects:
- Ensuring compliance with legal requirements in the registration of a marketing authorization license
- The procedures for performing the marketing authorization registration
- Document preparation for marketing authorization license registration
- Other related topics
– Depending on the info and customer requirements, we offer the following services based on customer needs:
- Checking and assessing the legal compliance of the documents and materials provided by the customer in the pharmaceutical registration dossier
- Drafting the drug usage instructions according to current regulations
- Designing drug label templates in compliance with labeling regulations
- Compiling and preparing the quality section of the dossier, including documents related to research and development, analytical testing, production and validation, etc
– Guiding customers through the procedures for submitting the pharmaceutical registration dossier to the Drug Administration of Vietnam (DAV) after content alignment and agreement.
– Supporting in amending and updating the dossiers adapting to the requirements of DAV in feedback letters (if any) until the product is granted the registration number.
– Providing guidance and recommendations for customers to store relevant documents when industry post-marketing surveillance is necessary.
SEN Pharma also offers services for the declaration of dietary supplements and cosmetics. For more details, please refer to the link below: