Drug registration service of SEN Pharma

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: