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)