Ágora Farmacéutica

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.)