Pharmacovigilance Services You Can Trust

Pharmaceutical, biotech and medical device companies operate in one of the most highly regulated industries globally. Ensuring patient safety while meeting global pharmacovigilance (GVP) requirements is a core responsibility that demands precision, consistency and a proactive approach. At FDAQRC, we provide comprehensive pharmacovigilance services through a vetted global network of experts who understand the complexities of drug safety, risk management and inspection readiness.

Our mission is clear: to help you safeguard patients, maintain compliance and optimize operational efficiency through a complete suite of global GVP compliance services.

What Are Pharmacovigilance Services?

Pharmacovigilance encompasses the science and activities involved in detecting, assessing, understanding and preventing adverse effects or other drug-related problems. For life science companies, robust GVP systems are essential—not only to comply with Good Pharmacovigilance Practices (GVP), but also to build public trust and protect their long-term brand reputation.

Pharmacovigilance services from FDAQRC go beyond baseline compliance. We deliver tailored, risk-based solutions that integrate seamlessly into your existing operations. Whether you’re preparing for global market entry, responding to health authority inquiries, or simply strengthening your internal processes, our consultants provide the clarity and expertise you need.

Our GVP Expertise

FDAQRC provides comprehensive pharmacovigilance consulting services tailored to meet the evolving needs of global life science organizations. Our areas of expertise include:

  • Routine pharmacovigilance audits
  • GAP Analysis 
  • For cause audits
  • GVP vendor and process audits
  • Mock Inspections
  • Internal Pharmacovigilance (GVP) system audits
  • Commercial partner audits
  • QMS audits
  • Qualification and re-qualification audits
  • Risk evaluation and mitigation strategies (REMS)
  • Postmarketing Adverse Drug Experience (PADE) Inspections

All our services are supported by our global consultant network—seasoned professionals with direct experience navigating health authority expectations across more than 70 countries.

Global Expertise That Inspires Confidence

FDAQRC stands apart due to our vetted global network of consultants, many of whom bring former experience in health authorities and the industry. This ensures that when you work with us, you gain access to deep insights into global regulatory expectations, from the FDA and EMA to MHRA, PMDA and beyond.

We operate with a commitment to precision and consistency, helping clients avoid the costly risks of noncompliance. More importantly, our approach is grounded in partnership: we embed ourselves into your processes to deliver solutions that are practical, scalable and sustainable.

Why Choose FDAQRC for Pharmacovigilance?

When you’re evaluating a pharmaceutical PV validation company, the stakes are too high to settle for partial solutions. Partnering with FDAQRC means:

  • Confidence in compliance: Our services are structured to meet the latest global standards in Good Pharmacovigilance Practices (GVP).
  • Operational efficiency: With streamlined processes and data-driven approaches, we reduce the burden on your internal teams.
  • Patient safety first: Every PV activity we deliver is designed to protect patient health and prevent safety signals from being overlooked.
  • Inspection readiness: Our clients trust us to prepare them for inspections and audits with confidence.
  • Global reach: With consultants in multiple regions, we provide consistent support wherever your products are marketed.

Integrated With Broader GxP Services

Pharmacovigilance does not exist in isolation. It is part of a broader compliance framework that includes computer system validation, quality management and other GxP disciplines. FDAQRC integrates pharmacovigilance services with this broader suite, enabling clients to achieve a unified compliance strategy that minimizes risk and maximizes efficiency.

Partner With FDAQRC for Pharmacovigilance Excellence

When patient safety and compliance are at stake, you need more than a service provider—you need a partner with the expertise, resources and dedication to deliver results. FDAQRC is that partner.

Our pharmacovigilance support services empower life science companies to operate with confidence, knowing they are fully prepared for inspections, audits and evolving regulatory demands. 

With a proven global network and a commitment to client success, FDAQRC is your trusted ally in safeguarding both patients and your organization’s reputation. Contact us today and discover how FDAQRC can strengthen your pharmacovigilance system.

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