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Make the uncertain,
certain.
Do you lose sleep
concerned about your
PV and Drug Safety readiness?
M2D Global Life Sciences, LLC
Assess and
Remediate PV
and Drug Safety
Functions
Design and Build
Worldwide PV
and Drug Safety
Departments
We can help.
We are PV professionals who
have countless hours in front of
worldwide regulators.
Our expertise...
Operational and Inspection
Preparedness
We perform detailed audits that encompass pre and
post-marketing environments…
Our Gap Assessments are guided by:
• Current Regulations and Guidance Documentation
• Significant inspection experience
• Predictive regulatory authority inspection targets
• Observed industry best practices
PV Functional Builds
and Enhancement Expertise
• Including case processing and safety database
vendor RFP, selection and deployment guidance
• Establishing effective governance, signal
management, global drug safety offices
• Providing certified change management and
Lean Six Sigma expertise
• Delivery of detailed, executive-ready project
status dashboards
M2D Global Life Sciences, LLC
Phone: 860-518-5571
Email: t.roe@m2details.com
Web: www.m2dteails.com
If you want to sleep better,
count on us instead.

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Brochure - PV Gap Assessments And Functional Builds

  • 1. Make the uncertain, certain. Do you lose sleep concerned about your PV and Drug Safety readiness? M2D Global Life Sciences, LLC
  • 2. Assess and Remediate PV and Drug Safety Functions Design and Build Worldwide PV and Drug Safety Departments We can help. We are PV professionals who have countless hours in front of worldwide regulators. Our expertise...
  • 3. Operational and Inspection Preparedness We perform detailed audits that encompass pre and post-marketing environments… Our Gap Assessments are guided by: • Current Regulations and Guidance Documentation • Significant inspection experience • Predictive regulatory authority inspection targets • Observed industry best practices PV Functional Builds and Enhancement Expertise • Including case processing and safety database vendor RFP, selection and deployment guidance • Establishing effective governance, signal management, global drug safety offices • Providing certified change management and Lean Six Sigma expertise • Delivery of detailed, executive-ready project status dashboards
  • 4. M2D Global Life Sciences, LLC Phone: 860-518-5571 Email: t.roe@m2details.com Web: www.m2dteails.com If you want to sleep better, count on us instead.