Pharmacovigilance Consulting

Moving Beyond Compliance
to Drive Growth

Pharmacovigilance is a growth driver when intelligence integrates across the entire value chain. Fidelity Health Services Pvt. Ltd. provides premier pharmacovigilance consulting services, assisting leading pharmaceutical companies in collecting and integrating safety data from various sources in real-time while ensuring patient safety and compliance. Our pharmacovigilance consultancy utilizes advanced technologies and analytics to boost revenue generation. By identifying gaps in your pharmacovigilance processes and implementing effective strategies, we enhance efficiency and effectiveness. We also help in selecting and deploying the most advanced technologies, transforming pharmacovigilance from a necessary task into a key growth enabler.


Trust Fidelity Health Services Pvt. Ltd. for comprehensive pharmacovigilance consulting services that boost your business beyond compliance, driving sustained growth and innovation in the pharmaceutical industry. Partner with us to see the full potential of pharmacovigilance services, ensuring your processes are not only compliant but also optimized for maximum business impact.

Improved Patient Safety

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Pharmacovigilance Consultancy
The Fidelity Health Services Way

Development of Quality system documents (SOP, WI, Policy, etc)

PV organizational structuring, planning, and governance

Computer System Validation

Trainings and
development

PV systems gap analysis and crisis management

PvOI
services

Regulatory
interaction

Auditing services (For external audits readiness)

Qualified Person for Pharmacovigilance (QPPV)

Local Qualified Person for Pharmacovigilance (LRPV)

Safety data exchange agreement (SDEA)

Computer System
Validation

Computer System Validation

In industries like pharmaceuticals, biotechnology, and medical devices, there is a need for validation programs to ensure that processes, equipment, materials, and systems deliver the expected results. Computerized systems that impact product quality, patient health, and good practices (GxP) must be validated to meet regulatory standards, ensuring data integrity, traceability, and product quality.

The implementation or upgrade of a computer system requires considerable time, cost, and resources for validation. With our in-depth understanding of the underlying software, Fidelity Health Services can accurately define the scope of the validation process, ensuring optimal efficiency in terms of time, budget, and effort.

Fidelity Health Services Pvt. Ltd. Validation Center of Excellence brings vast experience in leading complex validation programs for safety system implementations, upgrades, migrations, reporting, and integrations. Fidelity Health Services has created a range of accelerators designed to simplify and speed up the validation process.

Fidelity Health Services Pvt. Ltd. Validation Center of Excellence brings vast experience in leading complex validation programs for safety system implementations, upgrades, migrations, reporting, and integrations. Fidelity Health Services has created a range of accelerators designed to simplify and speed up the validation process.

Our Computer System Validation (CSV) consulting services encompass:
  • Ensuring regulatory compliance with authorities such as PMDA, EMEA, and FDA
  • Performance testing for Safety Systems to ensure optimal functionality
  • Adherence to 21 CFR Part 11 and EU Annex 11 compliance for Software and Systems
  • Validation strategies aligned with regulatory guidance for:
    • New Safety System implementations
    • Upgrades to existing Safety Systems
    • Data Migrations
    • Business Intelligence tools and Custom Reports
  • Implementation of the CSA, a risk-based validation approach as recommended by the FDA
  • Standardized validation packages to support Safety system implementation and upgrade programs:
    • Risk assessment, validation strategy, and planning
    • Authoring of validation scripts (IQ, OQ, PQ)
    • Test execution and summarization of results

What makes us preferred
Pharmacovigilance partner

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Helping you select and implement the most advanced and appropriate digital technologies that can transform pharmacovigilance from a necessary task to a growth enabler.
In an ever-changing pharmacovigilance landscape, we give you the confidence you need in your Pharmacovigilance Consulting solution
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