Risk Management Strategy Consulting

PrimeVigilance provides integrated risk management solutions for companies of various sizes, from single product biotech to international top-10 pharma companies.

PrimeVigilance experts can proactively assess product safety issues and risk factors at the patient level, this can also include predictive assessments if relevant. PrimeVigilance’s experts help design, implement and evaluate risk management systems and risk minimisation programs to meet global regulatory requirements. PrimeVigilance experts focus on approaches that maintain knowledge about drug safety issues, enable the prioritisation of safety issues as important risks, allow for the simple generation of RMP documents (development RMPs, company core RMPs, EU-RMPs, REMs and other types of RMP as required in various parts of the world), and integrate information on the effectiveness of risk minimisation into the risk knowledge base. These approaches have successfully contributed to more transparent decision making about risks the associated risk management and pharmacovigilance measures.