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Consultancy and technical support for the preparation of registration dossiers tailored to your specific requirements and liaison with the Health Authorities:

  • Regulatory strategies and development programmes.
  • Consultancy on legal requirements.
  • Assessment and evaluation of product dossiers.
  • Representation in regulatory procedures and relationship with local Regulatory Authorities.
  • Marketing Authorisation Applications.
  • Maintenance of marketing authorisations (variations, renewals, convalidations).
  • Reformat of dossiers in CTD format.
  • Expert reports.
  • Drug Master Files and Certificates of Suitability of the European Pharmacopoeia.
  • Price and reimbursement negotiations.
  • Laboratory and facilities authorisation.
  • Consultancy in promotion and advertising regulations

ÁGORA FARMACÉUTICA has a wide experience in the field of the Marketing Authorization Applications (National, Centralised, Decentralised or Mutual Recognition procedures) both for prescription and over-the-counter medications, as well as for other kinds of products (health products, medicinal plants, cosmetics, etc.)

ÁGORA FARMACÉUTICA, S.L.
c/ Juan Hurtado de Mendoza nš 9 - 809 . Madrid 28036. España. • Tel: +34 91 359 30 79. Fax: +34 91 345 25 18
agora@agorafarmaceutica.com