M2D Global Life Sciences, LLC specializes in pharmacovigilance (PV) and drug safety readiness, offering assessments and remediation of PV functions as well as the design of drug safety departments. Their services include operational preparedness, audits, gap assessments, and expert guidance on regulatory compliance and safety management. The company aims to enhance drug safety processes and provide comprehensive support to ensure clients meet industry standards.

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.