Time for a Rethink? Why Revisiting Your Compliance Contractors Could Be the Smartest Move You Make This Year
- Jackie Roberts
- Sep 6
- 2 min read
Updated: Sep 8
Let’s be honest—pharmacovigilance and regulatory contractors are often chosen in a rush. A new product launch, a sudden expansion, or a looming inspection deadline, and voilà: a vendor is onboarded, paperwork signed, and everyone breathes a sigh of relief. But fast-forward a few years, and that once-perfect fit might be showing signs of wear.
At PharmaGuard, we’ve seen it all: legacy contracts that no longer reflect the current regulatory landscape, vendors who’ve outgrown their boutique charm (or never quite delivered it), and systems that creak under the weight of modern PV and regulatory demands. So, here’s our gentle nudge: it might be time to revisit your contractor relationships—and here’s why.
1. The Regulatory World Has Moved On. Has Your Vendor?
The MHRA isn’t standing still, and neither are the EMA, FDA, or Health Canada. From evolving GVP modules to country-specific requirements (hello, NCPs, local QPPVs and PSMF localization), the rulebook keeps expanding. If your contractor hasn’t kept pace, you could be carrying the compliance risk—and that’s not a good look in an inspection.
Tip: Ask your vendor how they’ve adapted to recent regulatory changes. If the answer involves a shrug or a spreadsheet, it’s time to dig deeper.
2. Cost vs. Value: Are You Getting What You Pay For?
PV and regulatory consultancy isn’t cheap, and nor should it be. But value matters. Are you paying for rigid service models that don’t flex with your portfolio? Revisiting your contractor can uncover hidden inefficiencies, outdated pricing structures, and opportunities to renegotiate or re-tender. It’s not about penny-pinching—it’s about strategic spend.
3. Oversight Is a Legal Obligation, Not a Nice-to-Have
Let’s be crystal clear: outsourcing doesn’t mean offloading responsibility. As the MAH, you’re still on the hook for your products. If your contractor’s reporting is opaque, their KPIs are vague, or their audit trail is more breadcrumb than roadmap, you’re exposed.
4. Global Reach, Local Expertise
Expanding into new markets? You’ll need support that understands local nuances—from language-specific reporting to cultural sensitivities and regulatory quirks. A one-size-fits-all approach won’t cut it. Revisiting your contractor gives you a chance to assess whether they can truly support your global ambitions—or whether it’s time to find someone who can.
Final Thoughts: It’s Not About Blame, It’s About Fit
Revisiting your contractors isn’t a criticism—it’s a sign of maturity. Businesses evolve, portfolios shift, and expectations rise. The right contractor for 2020 might not be the right fit for 2025. And that’s okay.
At PharmaGuard, we believe in personalised support and tailored solutions to meet the unique requirements of each client, fostering a collaborative partnership. Transparency and open communication are key values at PharmaGuard, ensuring the client is kept informed every step of the way. Overall, transitioning to PharmaGuard promises a seamless experience coupled with exceptional service quality and efficiency, making it a reliable choice for those seeking a trustworthy partner.
If you’re ready to take a fresh look at your PV or regulatory setup, we’re here to help—whether it’s a full system review, a vendor audit, or just a friendly chat over coffee (virtual or otherwise).
