Pharmacovigilance Services

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At Clinetra Solutions, we understand that patient safety lies at the very heart of healthcare. In today’s highly regulated, fast-moving pharmaceutical landscape, it is not enough to develop life-saving drugs — you must also ensure their safety, monitoring, and compliance throughout the product lifecycle. That’s where our Pharmacovigilance (PV) expertise comes in.

We provide comprehensive end-to-end PV solutions that allow pharmaceutical, biotech, and CRO partners to meet global regulatory expectations while protecting patient health. From individual case processing to risk management and aggregate reporting, our skilled teams combine scientific expertise, medical insight, and technology-led efficiency to deliver results you can trust.

What sets us apart is our ability to blend human expertise with technology-led efficiency. Leveraging tools like AutoLit for automated literature monitoring and AI-driven workflows for data management, we help organizations move beyond reactive safety monitoring into a proactive, insight-driven model of pharmacovigilance. This means fewer risks overlooked, faster decisions made, and deeper confidence in meeting not just the letter of global regulations, but the spirit of protecting patients everywhere.

With more than 50,000 adverse event cases reported daily worldwide, pharmacovigilance has become the backbone of modern drug safety monitoring.

Our Pharmacovigilance Expertise

1. Case Processing & Safety Data Management We ensure accurate capture, review, coding, and reporting of Individual Case Safety Reports (ICSRs) in compliance with global standards (ICSRs/AEs/SAEs).
2. Literature Screening & Signal Detection Our teams proactively screen global medical literature and databases to identify potential safety signals, trends, and risks — helping you act early and confidently.
3. Aggregate Safety Reporting End-to-end preparation of PSURs, PBRERs, DSURs, RMPs, and risk evaluation updates as per EMA, FDA, ICH, and other regional authority guidelines.
4. Global Regulatory Submissions Timely preparation and submission of expedited and periodic safety reports through E2B-compliant electronic platforms recognized worldwide.
5. Risk Management & Compliance Monitoring Robust frameworks for Risk Evaluation and Mitigation Strategies (REMS), benefit-risk assessments, and ongoing safety monitoring to stay ahead of global compliance requirements.

Why Choose Clinetra for PV?

✔ End-to-End PV Services covering clinical trial and post-market phases
✔ Regulatory Global Reach – Expertise in FDA, EMA, MHRA, PMDA, Health Canada & more.
✔ Technology-Enabled Solutions – AI-assisted automation for case processing & literature search (integrated with AutoLit).
✔ Scalable Support – From start-ups to global pharma enterprises.
✔ Patient Safety First – Every action we take is driven by our commitment to safeguarding lives.

Industries We Serve
❄︎ Pharmaceutical & Biopharma Companies
❄︎ Contract Research Organizations (CROs)
❄︎ Medical Device Firms (combination products)
❄︎ Academic Research & Institutions
Your Safety, Our Priority

With Clinetra Solutions, pharmacovigilance becomes more than a compliance requirement — it becomes a culture of care. We stand with our partners to ensure that every product is monitored, every risk is managed, and every patient is protected.

Connect with our Pharmacovigilance team today to strengthen your safety strategy

Clinetra solutions, 3rd floor, Saptagiri complex, Pillar number-A743, Backside KPHB bus stop, Kphb Phase 1, Hyderabad, Telangana 500072

Designed & Developed by B G Krishna, +91 9494163200