PHASE I, II, III

REGULATORY APPLICATION/APPROVAL PHASE IV/POST-MARKETING 
  • Safety Planning 
  • AE/SAE Management 
  • Safety Reporting
  • Medical Monitoring 
  • PV Systems/Training 
  • Risk Management Plans  
  • GVP Audits of contractual partners, patient support programs, and other vendors, as applicable  
  • Audit/Inspections Preparations  
  • Post-Approval Safety/PV  
  • Safety Reporting (ICSRs and aggregate reporting)
  • Literature Screening  
  • Inspections Prep  
  • GVP audits  

 

GVP Expertise from A Highly Qualified Team

With Veristat and Certus PV, you balance therapeutic safety and risk at and beyond regulatory approval from a seasoned scientific team of pharmacovigilance experts

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100% of regulatory GVP inspections of our clients resulted in compliant ratings. In the past five years, no major or critical observations were received by our Clients for activities performed by Certus PV. 

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We are GVP experts:

40 years of PV experience  from Certus PV leadership

7+ years of PV experience on average from PV Managers and Associates

 

 Achieve Certainty in the Every-Changing PV Landscape

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Let's Talk.

We understand how challenging it is to manage your products' safety risks and deliver customized PV solutions throughout the duration of their lifecycle. We provide you with the certainty that your pharmacovigilance needs are being addressed comprehensively and proficiently. Our team of highly dedicated and experienced PV professionals ensures the fulfillment of your regulatory requirements through sound processes and efficient systems.

Learn more by contacting Veristat below or visiting  Certus PV.

 


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