Marketing Authorisation (MA)
- Preparation and submission of dossiers for MA applications (National, Decentralised and Mutual Recognition Procedures).
- Activities required for local compliance following Centralised Procedures.
- Co-ordination of MA Applications to ensure timely approvals via intensive follow-up correspondence and effective collaboration with Health Authorities.
- Consultancy services concerning local regulatory requirements.
MA maintenance and constant product update according to requirements:
- Post-approval notifications
- Sunset Clause
- Local contact point
Regulatory & Medical Documents
- Non-clinical and clinical literature overviews.
- Investigator’s Brochure (IB) sections.
- Investigational Medicinal Product Dossier (IMPD) sections.
- Regulatory review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling.
- Translations of Product Information (SmPC, Labeling and PIL) to local language.
- Regulatory review of packaging material.
- Regulatory review of promotional material.
Medical Affairs and Pharmacovigilance
- Educational Material local language translation, review and submission to Health Authorities.
- Direct Healtcare Professional Communication; preparation and / or local language translation, review, submission to Health Authorities and circulation to local Healthcare Professionals.
- Scientific and medical HCP communications or visits as partial fulfillment of local Medical Affairs or Medical Science Liaison (MSL) service.
- Local notifications of Medical Devices to local Health Authorities.
- Support for Technical File sections.
- Act as local contact point to Health Authorities.