Our experienced Regulatory Affairs Department’s goal is to give regulatory support to our clients, both during the pharmaceutical development as well as in the preparation of reports and specific requests:

  • Preparation of applications for orphan drugs designation (EMA and FDA).
  • Preparation of annual reports on the development of orphan drugs (EMA and FDA).
  • Preparation of scientific advice applications.
  • Holder of marketing authorizations for medicinal products for human use.
  • Preparation of marketing authorization applications (eCTD / NEES format).
  • Preparation of expert reports (Quality / pre-clinical / clinical summary and overviews).
  • Submission and monitoring -up to the approval- of applications for marketing authorization, including response to objection letters from the regulatory authorities.
  • Preparation of documentation necessary to request changes for marketing authorization.
  • Preparation of the required documentation for the five-year renewals of marketing authorizations (pharmacovigilance).
  • Translation of product information (summary of product characteristics, leaflet, labeling).
  • Realization of Readability Test or consultations to groups of patients.
  • Materials packaging management.

 

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