Regulatory Affairs
CIDP ensures you the best advice, assistance, assessment and confident submissions for your project on regulatory level.
- A consideration of regulatory strategies and alternatives at every step
- A guarantee of the adherence of ethical principles, regulations and appropriate guideline
- A constant collaboration with expert toxicologists
Our Services
- Regulatory compliance
- Monitoring (studies/ documents)
- Prepare and manage dossiers (CTA/IND/MAA/NDA/PIF etc.):
- Submission of Clinical Trial Applications
- Submission/ notification (registration dossiers)
- Safety assessment
- Advise (tests/ regulatory documents)
- Claims validation/compliance
- Label validation
- Reimbursements (quotations/ notifications)
- Due diligence strategies
- Post Marketing Safety Surveillance (Cosmetovigilance/ Pharmacovigilance)