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.