Regulatory Affairs

Regulatory Affairs:

This department is responsible for the submission and monitoring of registrations required in each case until they are approved, and for keeping the registrations up-to-date over time, as well as for pharmacovigilance as required throughout the marketable life of the products developed.

Fast, efficient and profitable management in the Regulatory Affairs area, supported by the expertise of our specialists and by their experience in the areas of quality, clinical work, manufacturing and registration of ethical, generic, and advertising medicinal products and medical devices, etc.

Arafarma Group provides a streamlined and efficient solution for those specialised services that pharmaceutical laboratories require.

We take into consideration that each project undertaken in partnership represents a key process for our customers

Arafarma Group offers in the field of Regulatory Affairs:

  • Design of registration dossiers.
  • Complete development of the registration of a medicinal product (ethical, generic, advertising, etc.) in both the experimental as well as documentary parts.
  • Preparation of the dossier’s registration documentation for the marketing authorisation.
  • Drafting of experts’ reports.
  • Validation and submission of registration dossiers.
  • Follow-up of registration dossiers with the AEMPS.