Regulatory and Pharmacovigilance Support

 Within a continuously changing regulatory environment, partner 4 health team offers their knowledge and effective support for regulatory and safety departments to gather and analyze date, and writing:

• Non-clinical ICH Modules

• Clinical ICH Modules

• Response to regulatory bodies questions

• Investigator's brochure (IB)

• Clinical study protocol (CSP) and related documents

• Clinical study report (CSR)

• IND Briefing documents

• EMA scientific advice documents

• Pediatric Study Plan and Amendments (FDA)

• Pediatric investigational plan (EMA)

• Orphan drug designation (ODD; FDA and EMA)

• Integrated summaries of safety and efficacy

• Periodic benefit-risk evaluation reports (PBRERs) and similar documents

• Risk-benefit assessment and design of Risk Minimization Plan

• Development safety update reports (DSURs)

• Addendum to clinical overviews (ACO)

• Scientific and medical review of registration documents

We have vigorously and successfully accompanied biotech and big pharma companies in preparing and presenting their plans, dossiers, and briefing documents.