E2B R2 and R3 Reporting

30+ Organizations using Vitrana’s TransformPV and/or PVFilter

• EMA R3
• FDA VAERS
• FDA eMDR
• FDA PMSR
• PMDA (Japan)
• CDE (China)
• Korea R3
• EU MIR

Integrations in production with both.

Proven experience of implementing R3 requirements for 30+ organizations

Actively engaged with regulatory agencies to discuss improvements in guidance resulting in guidance updates.

Detailed understanding on existing R3 guidance including EMA, FDA VAERS, FDA eMDR, FDA PMSR, PMDA R3, China R3, Korea R3 reporting requirements.

Use of accelerators like regional guidance assessment to expedite business understanding of R3 regulations.

Providing best practices and lessons learned on R3 implementation process enabling organizations to rollout R3 effectively.