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.