Regulatory & Vigilance Support
Marketing Authorisation (MA)
- Submission of dossiers for MA applications.
- Activities required for local compliance.
- Co-ordination of MA Applications to ensure timely approvals.
- Consultancy services concerning local regulatory requirements.
Product Maintenance
- Variations
- Renewals
- Post-approval notifications
- Sunset Clause
- Local contact point
Regulatory & Medical Documents
- Non-clinical and clinical literature overviews.
- Investigator’s Brochure (IB) sections.
- Regulatory review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling.
- Regulatory review of packaging material.
- Regulatory review of promotional material.
Pharmacovigilance & Scientific Affairs
- Local contact point for Pharmacovigilance.
- Local literature review.
- Educational Material local language review & coordination with Health Authorities.
- Direct Healtcare Professional Communication review, coordination with Health Authorities and circulation to local Healthcare Professionals.