Regulatory activities

Developing a regulatory strategy:

– depending on the type of product to be marketed, we propose an appropriate regulatory strategy based on your dossier assessment and include the necessary preparation of the dossier in accordance with national requirements, submission and follow-up of the procedure and timely communication with the relevant authorities.

  • 1. Scientific development and preparation of complete eCTD dossiers for new medicinal products under national procedures - all modules or individual sequences;
  • 2. All registrations of a medicinal product under national authorization procedures: - Filling in Applications under National Authorization Procedures for Medicinal Products; - Product information for the medicinal product: Summary of Product Characteristics (SPC), Package Leaflet, Packaging Data, including translations.
  • 3. Full co-operation on completion of the national MRP / DCP phase;
  • 4. Maintenance of post-marketing dossiers of authorized medicinal products - changes to the marketing authorization of a medicinal product, - renewal of the authorization for the use of a medicinal product; - transfer of the marketing authorization for the medicinal product; and other actions relating to the maintenance of the dossier for medicinal products;
  • 5. Evaluation and updating of the regulatory documentation;
  • 6. Quality review, non-clinical and clinical reviews;
  • 7. Leaflet Readability Test;
  • 8. Communication with the Bulgarian Drug Agency (BDA).
  • 9. Local representation and communication with the Executive Agency for Drugs (BDA) for MRP / DCP.