Pharmacovigilance

vigilance - the ACTION of keeping careful watch for possible difficulty or danger; a RESPONSIBILITY

Robust pharmacovigilance programs protect public health through the scientific detection, assessment, understanding and prevention of drug related adverse effects and other potential problems. Globalization and increased scrutiny by regulatory authorities continues to challenge even the most sophisticated data monitoring systems.

From preclinical studies to post-marketing settings, The Catalyst Group has   the expertise to provide comprehensive clinical and post marketed drug safety consulting services to help you address product safety concerns in a confident, proactive manner.

  • Adverse Event Monitoring
  • REMS
  • Aggregate Reporting
  • Mock Safety Audits
  • Literature Review
  • Legal Nurse Consultant Review

"The Catalyst Group team really helped us achieve organization and compliance out of chaos. A deep understanding of regulatory requirements and sharing of many “lessons learned” helped us implement a truly robust CAPA system that has been recognized as best practice by our peers."

QA Compliance Head, Medical Device Startup

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Failure to follow established company procedures was one of the top three reasons for FDA 483 observations in 2013. Discover 3 ways you can minimize human error right now.

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