Regulatory Affairs
Regulatory strategy and submissions for drugs and devices, ensuring compliance and smooth approvals.
CTA submissions
- CTIS preparation: Clinical Trial Information System documentation and setup
- Multi-country coordination: EU-wide submissions via single portal
- Protocol optimization: Regulatory-compliant study design and endpoint selection
- Timeline management: Streamlined approval process and regulatory milestones
Medical Device Submissions According to MDR
- Clinical investigation applications:
CIP submissions and notified body coordination - Clinical evaluation:
MDR-compliant clinical evidence and literature review - Technical documentation:
Annexe II and III preparation for CE marking - Post-market surveillance:
PMCF plans and clinical follow-up requirements
- Clinical investigation applications:
Communication with Regulatory Authorities (drugs & devices)
- For Drugs:
- Scientific advice:
EMA protocol assistance, FDA meetings, URPL consultations - Submission support:
CTA/IND correspondence and regulatory question responses - Global coordination:
Multi-regional strategies and timeline management
- Scientific advice:
- For Medical Devices:
- Notified body interactions:
Technical reviews and clinical evidence discussions - FDA device consultations:
Pre-submission meetings and classification guidance - Regulatory liaison:
Competent authority communications and MDR compliance
- Notified body interactions:
- For Drugs:
De novo and 510(k) submissions (FDA)
- De novo pathway:
Novel device classification and predicate analysis - 510(k) preparation:
Substantial equivalence demonstration and comparative data - Clinical evidence strategy:
FDA clinical requirements and study design - FDA interactions:
Q-Sub meetings, pre-submission consultations, and approval tracking
- De novo pathway:
Post-marketing regulatory support (drugs & devices)
- For Drugs:
- Safety surveillance:
PSUR preparation and pharmacovigilance reporting - Regulatory variations:
Label updates, indication extensions, and lifecycle changes - Compliance support:
Inspection preparation and audit assistance
- Safety surveillance:
- For Medical Devices:
- Post-market surveillance:
PMCF studies and vigilance reporting - Device modifications:
Design changes and performance improvements - MDR maintenance:
Annual reports and registration updates
- Post-market surveillance:
- For Drugs:
