Pharmacovigilance | Pre-Approval and Post-Marketing PVG and Safety Surveillance

Delivering safety surveillance before and after regulatory approval

Veristat has expanded its pre-approval and post-marketing pharmacovigilance and safety monitoring support with the acquisition of Certus PV. The combination creates a unique and unrivaled team of safety and pharmacovigilance experts who offer pre-approval support for drug developers working to get therapies approved and post-marketing support for marketing authorization holders/applicants to keep their products on the market.

Demonstrating patient safety throughout the entire product development lifecycle requires years of experience, expertise with regulatory agency interactions, and a proven history of success.

Ensuring Drug Safety Across All Phases of Development and Post-Approval 

While it is critical to ensure patient safety throughout clinical trial planning, execution, and the regulatory approval process, it doesn’t end there. Once a therapeutic receives regulatory approval, long-term safety monitoring begins to ensure continued patient safety.

We can help you develop, negotiate, and implement your Risk Management Plans with the regulatory agencies. The process begins during the preparation of the marketing application (e.g., NDA, NDS, BLA, etc.) and continues post-approval for the entire time the product/therapeutic is on the market.  

Providing Expertise to Tackle Challenges Big or Small At Each Stage of Development

PHASE I, II, III	REGULATORY REGISTRATION	PHASE IV AND 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/Inspection Preparations  and Responses	Post-Approval Safety/Pharmacovigilance Safety Reporting (ICSRs and aggregate reporting) Literature Screening  Agency Inspection Preparation and Responses GVP Audits  Medical Information Call Center Support

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.

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. 

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 Ever-Changing PV Landscape

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.

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Pharmacovigilance and Safety Surveillance for Pre-Approval and Marketed Health Products

Delivering safety surveillance before and after regulatory approval

Ensuring Drug Safety Across All Phases of Development and Post-Approval

Providing Expertise to Tackle Challenges Big or Small At Each Stage of Development

GVP Expertise from A Highly Qualified Team

Achieve Certainty in the Ever-Changing PV Landscape

Let's Talk.

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Ensuring Drug Safety Across All Phases of Development and Post-Approval 