Pharmacovigilance Compliance for Small and Mid-Sized Pharma: What You Need to Know

Pharmacovigilance (PV)—the monitoring of drug safety — is critical to the safety of medicines, ensuring that adverse effects are detected, assessed, and managed to protect public health. As soon as a drug enters the market, the responsibility shifts from pre-approval clinical oversight to ongoing, post-market vigilance. But with that comes growing data, regulatory expectations, and system demands that can quickly overwhelm lean teams.

This blog breaks down the key PV compliance challenges—and practical solutions—for emerging pharmaceutical companies.

What Is Pharmacovigilance, and Why Does It Matter?

Pharmacovigilance refers to the collection, monitoring, analysis, and reporting of adverse events and other drug-related problems once a product is used in the general population. Unlike the controlled conditions of clinical trials, real-world use introduces variability in age, comorbidities, and off-label usage—making PV critical for capturing safety signals that may not have surfaced in earlier phases.

For small companies, maintaining PV compliance ensures:

• Regulatory trust with agencies like the FDA and Health Canada

• Early detection of safety concerns

• Informed updates to prescribing information

• Risk mitigation and stronger market sustainability

The Data Challenge: Volume, Variability, and Velocity

As Betty Cory, President of Regxia, emphasized in the Driving the Business of Science podcast, today’s pharmacovigilance landscape is dominated by one word: data.

Patients are more informed and empowered to report drug effects. More data comes in, from more sources, at a faster pace. Each report demands context—patient age, concurrent medications, dosage, timing, outcome—and follow-up. This isn't something that can be managed with spreadsheets or sticky notes anymore.

The problem? Most PV systems are built for Big Pharma. They're expensive, overengineered, and require in-house IT infrastructure. For smaller sponsors, that’s an impossible equation.

Common Barriers for SMBs to Adopting Electronic PV Systems

1. High system costs: Enterprise-level PV platforms often cost hundreds of thousands of dollars.

2. Over-complexity: Systems may offer more than needed, complicating implementation and training.

3. Limited IT support: Without a dedicated tech team, system validation and maintenance become risks and Agency observations.

Fit-for-Purpose Technology: A Smarter Approach

Regxia’s approach, in partnership with Court Square Group, is built around a “fit-for-purpose” mindset. For small sponsors, this means a PV system that is:

• Affordable: Aligned to the scale and scope of a smaller portfolio

• Usable: Easy to adopt without extensive IT or regulatory expertise

• Compliant: Validated and audit-ready to meet Health Canada and FDA requirements

• Collaborative: Built to keep companies involved in data adjudication, not removed from it

As Betty Cory noted, the goal isn’t to build a system that mimics large pharmaceutical infrastructure—it’s to support science-driven companies with tools that let them focus on their drug, not their tech stack.

Outsourcing vs. Ownership: Striking the Right Balance

The hurdles many SMBs encounter with their PV activities and IT infrastructure lead to the logical consideration of outsourcing PV operations altogether, but there are tradeoffs. While outsourcing can provide immediate relief, it can also create a black box: events are handled, but not truly seen or understood by the company.

That’s risky—especially when a product is novel, targeted, or designed for rare disease populations. The sponsor knows the compound best. Being hands-on with safety data helps detect subtle but critical patterns early.

Betty recommends finding partners who can act as extensions of your internal team, rather than siloed vendors utilizing systems with limited transparency. In her words: “Don’t lose sight of what you’re trying to accomplish. PV isn’t just about checking a compliance box. It’s about protecting patients—and understanding your product in the real world.”

What You Need: PV Compliance—Without the Complexity

If you're a small or mid-sized pharma company preparing for launch or navigating early commercial phases, here’s what to prioritize:

✅ An electronic PV system that is validated, secure, and audit-ready

✅ A trusted partner who understands your scale and science

✅ Hands-on data access so your team can detect emerging safety signals

✅ Clear documentation to streamline annual safety reports and inspections

Final Thought

Pharmacovigilance is more than just a regulatory checkbox—it’s a core part of responsible drug development. For emerging biopharma companies, the path forward lies in finding right-sized solutions that align with their scale, and structure.

With the right tools and partnerships, PV compliance becomes not just manageable—but a strategic advantage.

If you're looking for a simplified, cost-effective PV approach tailored to small pharma, reach out to the teams at Regxia and Court Square Group. We’re here to help you stay compliant—and stay focused on the science that matters.