Is Your Organization Ready for a Successful Launch?

A positive Phase III readout is only the beginning. Use this self-assessment to evaluate your governance, safety systems, country readiness, and front-line operations—before commercial activity exposes the gaps.

Download the Checklist →

 

As products move from development to commercialization, pharmacovigilance requirements expand dramatically. New indications, new markets, and new healthcare professional audiences introduce operational complexity that many organizations underestimate—and launch delays frequently trace back to safety systems that were never fully validated under commercial operating conditions.

This pre-launch readiness checklist gives PV, regulatory, and quality leaders a structured way to assess whether their infrastructure can support a compliant, controlled, and confident launch.

The checklist walks through seven assessment sections covering the full scope of pre-launch PV readiness:

• Organizational Readiness — governance, QPPV responsibilities, vendor oversight, and escalation pathways
• Infrastructure Assessment — safety database configuration, product coding, literature monitoring, and workflow validation
• Country Preparation — local regulatory mapping, reporting timelines, affiliate training, and pathway testing
• Market Readiness — Risk Management Plans, aRMMs, educational materials, signal detection, and inspection readiness
• Front-Line Readiness — medical information intake, AE channels, HCP inquiry processes, and contact centre training
• Local Market Compliance — country-specific obligations across Japan, EU, China, GCC, and Canada
• Launch Simulation — a mock-launch exercise to pressure-test your team’s ability to receive, assess, report, detect, and escalate

Whether you’re approaching your first commercial launch or scaling into new regions, this is the structured self-assessment your cross-functional team can work through together.

Download the checklist to assess your readiness across governance, infrastructure, country preparation, and front-line operations—and see exactly where your organization stands before launch day.