Effective Regulatory Intelligence in PV White Paper

Effective regulatory intelligence in pharmacovigilance with FSP partnerships

Pharmacovigilance (PV) is a critical component of drug and medical device development and commercialization. Effective PV regulatory intelligence (RI) is important to ensure that PV is executed accurately and cost-effectively.

Many pharma, biotech and medical device companies rely on functional service provider (FSP) partnerships to ensure comprehensive and cost-effective PV RI.

This white paper outlines some of the key PV RI capabilities that distinguish top-tier FSP PV partners from other service providers, including:

• Monitoring regulation changes
• Analyzing and interpreting regulations and guidance
• Communicating regulatory requirements and operationalizing change
• Guiding the development of new and updated regulations and guidance