Drug registration service of SEN Pharma

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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:

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