PRA designs and implements the proper safety procedures from the early stages of product development right through to market, allowing for clear assessment and communication of efficacy and safety.
PRA's services include:
- Product life cycle Pharmacovigilance Plan
- Risk Management Planning
- Risk Evaluation and Mitigation Strategy (REMS)
- Risk Management Plan (RMP)
- Product specific Risk Identification, Assessment and Minimization pre- and post-approval
- Full SAE/ADR/MDR management
- Benefit-Risk Assessments and Investigation of safety issues
- Analysis and communication of safety issues
- Pre- and post-approval Risk Management Programs
