Phlox PVMed Consultancy

Phlox PVMed Consultancy has decades of expertise in the preparation of aggregate reports that are aligned with other documents such as Investigator Brochures, Company Core Datasheets and product Risk Managment Plans, with a track record of the report being accepted by regulatory agencies without further comment or requests for change or further information.

• Periodic safety update reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) to ICH E2C requirements
• Development safety update reports (DSURs) to ICH E2F requirements
• Risk Managment Plans to EU, Australian and UK requirements
• Risk Evaluation and Mitigation Strategies (REMS) to US FDA requirements
• Health Authority Safety Review Request (HASRQ) response documents

• Create the initial strategy, preparation and production of first DSUR, PBRERs and RMPs
• Work with vendors to order and QC reports for inclusion in correct format
• Create company specific templates
• Support single reports or write multiple aligned reports
• Provide medical writing and document management and facilitation