Synowledge can help drug companies identify, monitor, and manage the quality and safety risks associated with their products , in accordance with the REMS/RMP requirements that the FDA and EU authorities enforces as part of the drug life-cycle management. Synowledge RMP/REMS solutions include the time-effective, and quality- assured management of all RMP/REMS activities, from planning initiatives to program assessments.
The following services are offered by our dedicated Regulatory Affairs group at Synowledge:
Helping you to prepare the quality and safety Risk management methodology
Risk management planning
Risk Management Plan (RMP) development
Writing Risk Management Plan (RMP)
Writing an Environmental Risk Assessment (ERA)
Development of risk minimization/mitigation tools
Assessment of risk minimization/mitigation strategy
