Regulatory Affairs


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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