RMP- Risk Management Plan

We are leaders when it comes to integration with sponsors' safety CMO units to provide complete material-ready RMPs for regulatory submission due to our agile process and proficiency in dealing with businesses of all sizes. Over years, we have dealt with RMPs for pharmaceuticals, biosimilar, combination products, vaccines and biologics. Running a single shared REMS programme required by FDA was a skill that COD team members have mastered. We also support our clients through the REMS development process with expertise. • Preparation (Core RMP, EU RMP, Local RMP, REMS) • SME Review • RFI response • Single Shared System REMS expert Support