Leverage our experienced staff (including former PV Dept. Heads and Ex-Regulators) to establish effective benefit-risk strategies for positive regulatory outcomes
Expert Pharmacovigilance Guidance
Leverage our experienced team for seamless support on safety sections of the NDA, BLA, and MAA (including Modules 2.5 and 2.7.4, and CSRs) throughout the submission process
Develop CCSI as well as local labelling methodology
Benefit from end-to-end assistance in preparing, reviewing, and managing critical regulatory filing documents
Streamline your pathway to market with strategies designed to reduce timelines and optimize regulatory outcomes
Regional Expertise
Develop strategy and delivery of regional-specific ex-US requirements such as the PSMF, RMP, Set-up and management of the Article 57 database
Design and implement regional QPPV network
Support REMS development and delivery
Preparation for Post-Marketing PV
Lead PV Road Show to educate corporation on compliance with post-launch PV requirements and expectations
Collaborate with corporate stakeholders to establish appropriate collection mechanisms for adverse events across the organization
Build post-marketing case processing unit
Enhance safety governance to align with post-marketing regulations
Design PV regional infrastructure expansion to support affiliate models
