Regulatory Affairs

MEDICINES:

Pre-authorization: regulatory strategy definition; MAA - National Procedure, Mutual Recognition Procedure, Decentralised Procedure, Centralised Procedure, Nees and eCTD formats.

Post-authorization: Marketing Authorization Renewals, Marketing Authorization Variations and Transfers of Marketing Authorization Holders preparation, submission and follow-up.

Scientific Services: SmPC - Summary of Product Characteristics, PIL - Patient Information Leaflet and Labelling Texts elaboration, review and translation. Readability Tests and Bridging Reports.

Herbal Medicinal Products: Product Quality Dossier, Traditional Use Registration, Well-established Use Marketing Authorisation, Stand-alone or Mixed Application.

MEDICAL DEVICES:

Technical Documentation: elaboration of technical documents, labels and instructions of use.

Market Surveillance: update in regulation and product documentation.

Authorized Representative: technical documentation, quality assurance, pharmacovigilance and CE marking by the certified body management.

Product Notification: authority notification procedure.

EMA, INFARMED, ANVISA and FDA contact person.