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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. 

Medical and Scientfic Writing
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