Risk Management, RMPs, and REMS

Regulatory Documentation

Regulatory Documentation for a Risk Management Plan (RMP)

A RMP consists of seven parts: Product Overview, Safety Specification, Pharmacovigilance Plan, Plans for Post-authorisation Efficacy Studies, Risk Minimisation Measures, Summary of Activities in the RMP, and Annexes. The Safety Specification consists of eight separate modules, some having multiple sub-sections. The Pharmacovigilance Plan, Plans for Post-authorisation Efficacy Studies, Risk Minimisation Measures, and Summary of Activities in the RMP each have multiple sub-sections.

Regulatory Documentation for a Risk Evaluation and Mitigation Strategy (REMS)

A REMS can include a Medication Guide, Communication Plan, Elements to Assure Safe Use (ETASU), and an Implementation System. It must include a statement of the REMS goals and a Timetable for Assessment of the REMS. A REMS submission consists of a Proposed REMS, which includes REMS-related materials as Appendices, and a REMS Supporting Document.

What makes the ParagonRx approach to regulatory documentation unique?

  • Our staff has a unique combination of regulatory insight; deep pharmaceutical company experience across the product life-cycle; care management, risk management, pharmacovigilance, pharmacy, and clinical expertise; and superior writing skills.
  • We are highly experienced in creating customized regulatory documents of varying levels of complexity.
  • Our track record for timeliness and quality of regulatory documents is unsurpassed: all documents have been successfully submitted within client timelines and/or regulatory commitment dates, and none were rejected or required rewrites.