Safety Simplified

NovaVire was founded on the belief that pharmacovigilance must continuously evolve to protect patients in an ever-changing regulatory and therapeutic landscape.
The name NovaVire reflects this philosophy - β€œNova” signifies renewal and progress, while β€œVire” represents strength, vigilance, and protection of life.

Trusted by Global Pharma Leaders

150+

Systems Validated

40+

Global Organizations

100%

Compliance Rate

24/7

Support Services

Why Choose Novavire?

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Deep PV Expertise

Specialized in Argus, Veeva Vault, LifeSphere, ArisGlobal platforms with 10+ years experience

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Regulatory Alignment

FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ Data Integrity certified

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Rapid Deployment

Agile validation approaches enable faster time-to-market without compromising quality

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Global Support

Operating across Americas, EMEA, Asia-Pacific with round-the-clock managed services

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Quality Assurance

100% audit-ready documentation with zero compliance gaps in inspections

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Flexible Engagement

Customized models: Project-based, Dedicated Teams, or Managed Services

Core Service Areas

CSV

Computer System Validation

End-to-end CSV for safety systems. URS, FS, Risk Assessment, IQ/OQ/PQ execution

Safety

Safety System Services

Configuration, integrations, E2B gateways, regulatory reporting setup

Managed

Managed Services

24/7 monitoring, incident management, continuous compliance validation

Validation Approaches

Traditional Validation

For structured environments requiring complete IQOQPQ execution with comprehensive documentation

  • Full regulatory compliance
  • Complete traceability
  • Controlled governance

Agile Validation

For organizations adopting frequent releases with iterative validation cycles

  • Faster deployment
  • Incremental evidence
  • Reduced effort

AI-Assisted Validation

Leverage automation and AI for documentation, testing, and impact assessment

  • Automated regression tests
  • AI documentation
  • Rapid evidence extraction

Ready to Transform Your Safety Systems?

Let's build validated, compliant, and scalable environments together

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