A tailored service providing assurance of compliance, at the forefront of industry best practice
 

Good Pharmacovigilance Practice (GVP)

Global Pharmacovigilance (PV) auditing services to ensure GVP compliance. We audit systems, affiliates, and business partners to safeguard your safety data.

We provide end-to-end GVP quality assurance, from Pharmacovigilance System Master File (PSMF) audits to local affiliate inspections. Our experts help you prepare for regulatory inspections by identifying gaps in your safety signal management, case processing, and QPPV oversight. Ensure your PV system is robust and inspection-ready with Adamas.

Focused.
Tailored.
Cutting Edge.

ASSURANCE AND CONFIDENCE ARE VALUES WE LIVE BY AND WE UNDERSTAND THEY UNDERPIN YOUR COMPLIANCE ACTIVITIES

Featured Resources

For a deeper dive into the ICH E6(R3) guidelines, check out our latest expert insights.

Webinar

ADAMAS Consulting’s webinar, “GCP ICH E6 R3 Unveiled: Navigating the Evolving Roles of Sponsors and CROs,” provides invaluable insights into the evolving landscape of Good Clinical Practice (GCP) guidelines.

Case Study

Our latest case study highlights how ADAMAS Consulting supported a leading pharmaceutical company in proactively identifying high-risk sites during a global Phase III oncology trial—aligning with ICH E6 (R3) guidelines.

Guide

In this free guide, we break down the most critical updates to ICH E6(R3)—and provide practical, inspection-ready strategies to help you stay compliant, audit-ready, and ahead of regulatory expectations.

OUR IN-HOUSE GVP TEAM HAS BEEN STRATEGICALLY DEVELOPED TO ENSURE OUR CLIENTS RECEIVE THE HIGHEST LEVEL OF EXPERTISE BOTH AT THE GVP SYSTEMS AND PROCESS AUDIT LEVEL

Our Views

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COVID-19 | Pharmacovigilance Update

In response to the COVID-19 pandemic, the Food and Drug Administration (FDA), European Medicine Agency (EMA) and other national health authorities have published...
ADAMAS PODCAST

MAINTAINING INSPECTION READINESS

Jessica Syverson – Consultant
ADAMAS Consulting

As regulatory authorities continue to outline their expectations for maintaining compliance during the pandemic, including the conduct of GxP inspections remotely, maintaining inspection readiness remains an important activity.
With our team of ex-inspectors, ADAMAS is well placed to assist with conducting mock inspections remotely.

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