Need a regulatory compliant pharmacovigilance Software ? Look no further. Start with Glaers

Trusted Pharmacovigilance Consulting for Pharmaceutical Biotech & Medical Device Companies

Integrated Software & Consulting Solution

100% Regulatory Compliance & Reports Audit Trail

E-Sign and Inspection Readiness

Periodic and Annual Reports for Submission

GLAERS PV Consulting Solution

Solutions that ensure continuous patient safety and regulatory compliance

Talk To Our PV Expert

Patient safety is at the heart of every successful pharmaceutical product. Glaers Pharmacovigilance (PV) Consulting Services help companies establish compliant, scalable, and inspection-ready pharmacovigilance systems that meet global regulatory requirements.

From clinical development through post-marketing surveillance, our experienced pharmacovigilance consultants provide strategic guidance, operational support, regulatory compliance, and risk management solutions aligned with FDA, EMA, MHRA, PMDA, Health Canada, TGA, CDSCO and other international health authorities.

Whether you require complete PV outsourcing, process optimization, local QPPV support, software implementation, or regulatory inspections preparation, we deliver tailored solutions that ensure continuous patient safety and regulatory compliance.

Deep Pharmacovigilance Expertise

Our consultants possess extensive experience across global regulatory frameworks, helping organizations establish compliant and scalable pharmacovigilance operations.

Inspection-Ready Processes

Our quality-driven approach ensures your pharmacovigilance systems remain audit-ready at all times.

Flexible Engagement Models

  • Strategic Consulting
  • Project-Based Support
  • Dedicated Resource Model
  • Managed Services
  • Full PV Outsourcing
OUR SERVICES

Our Pharmacovigilance Consulting Services

We provide end-to-end pharmacovigilance consulting across to ensure complete regulatory compliance.

Adverse Event Intake Services

Capture and process safety information from multiple reporting channels.
Supported sources:

✔ Email
✔ Web Portal
✔ Medical Information
✔ Sales Representatives
✔ Healthcare Professionals
✔ Patients
✔ Distributors
✔ Product Complaints

Individual Case Safety Report (ICSR) Management

Efficient adverse event processing throughout the product lifecycle.

✔ Case Intake
✔ Case Triage
✔ Medical Coding(MedDRA)
✔ Narrative Writing
✔ Medical Review
✔ Follow-up Management
✔ Expedited Reporting
✔ XML Format Generation
✔ Health Authority Submissions

Aggregate Safety Reporting

Preparation of global safety reports compliant with international regulations.

✔ PSUR
✔ PBRER
✔ DSUR
✔ PADER
✔ Development Safety Reports
✔ Annual Safety Reports
✔ Benefit-Risk Evaluation Reports

Audit & Inspection Support

Prepare your organization for regulatory inspections.

✔ PSMF Authoring and Update
✔ SOP development
✔ Audit readiness
✔ Compliance monitoring
✔ Periodic checks
✔ Inspection support
✔ CAPA management

Technology Services

Establish inspection-ready pharmacovigilance infrastructure.

✔ ADR Intake and Case Processing Software
✔ Safety Database Hosting & Implementation
✔ Data Migration Services
✔ Validation and Qualification (IQ, OQ, PQ)
✔ Automation Tool Development

Industries We Serve

Our solution is designed to serve across lifescience industry where consumer safety and regulatory compliances are required.

Pharmaceuticals

Biotech

Medical Device & IoT

CROs and CDMOs

OTC and Cosmetics

Food & Nutraceuticals

Transparent Pricing for Every Stage of Your PV Safety and Compliance. Get Pricing that fit your requirements.

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Benefits of Our Pharmacovigilance Outsourcing

GLAERS provides unmatched solution and technology support to meet your business and regulatory compliance needs.

  • Global Regulatory Compliance
  • Audit Readiness
  • Cost-Effectiveness, Affordable Pricing
  • No Software Licensing and Maintenance Burden
  • Periodic and Annual Reports
  • Scale Global Safety Operations
  • Optimize Pharmacovigilance Costs
GLAERS Pharmacovigilance Team