Laboratorios Alcalá Farma

R&D

Regulatory Affairs / Medical Section

  • Expert reports
  • Coordination of clinical tests
  • Formulation of products
  • Scientific advice
  • Product Monograph

Regulatory Affairs Department:

Our Regulatory Affairs Department is responsible for:

  • Preparation of registration dossiers for requesting authorisation from the AEMPS on generic and ethical medicines, and advertising.
  • Monitoring of registration applications, of the dossiers presented in the name of our laboratory.
  • Responding to letters finding fault with the dossiers charged to us by laboratory customers.

Medical Department:

Our Medical Department is responsible for:

  • Preparing the Clinical and Preclinical part of the Registration Dossier (expert reports, specifications, modules 4 and 5)
  • Studying the clinical viability and support documentation of the effectiveness and safety of our new R&D projects.
  • Arranging with the clinical pharmacological units of Universities/the CRO to conduct clinical tests of the projects entrusted to Alcalá Farma.
  • Institutional relationships with the Spanish Medicines Agency for the dossiers which Laboratorios Alcalá Farma present to the medical authorities.