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ZenithPV

Frequently Asked Questions

At Zenith PV, we know pharmacovigilance can raise a lot of questions whether you're navigating Health Canada GVP or scaling your drug safety team. Below, we've organized our most common inquiries into categories for easy reference. Can't find what you need? Reach out via our contact form for personalized guidance.

General Questions

Zenith PV is a boutique pharmacovigilance firm founded in 2020 by Manar Hammood, specializing in customized PV solutions for mid-sized pharmaceutical companies developing prescription drugs, advanced biologics, and medical devices.
We serve developers of marketed pharmaceuticals, specialty medications, DINs (Rx and OTC), NPNs, medical devices, and more focusing on Canadian businesses seeking compliant, nimble support.
Our approach is listening-first: We conduct gap analyses to hand-craft boutique services, ensuring direct senior partner access, transparent billing, and proactive solutions that build physician confidence in your products.

Services and Solutions

We provide integrated pharmacovigilance for drug safety, including bilingual ICSR processing, literature screening, Canada Vigilance Database screening, foreign actions monitoring, validated safety database access, and PV trainings—all tailored to exceed Health Canada GVP requirements.

Our end-to-end service covers case intake, data entry, MedDRA coding, narrative writing, medical assessment, quality checks, safety mailbox management, and electronic submissions to Health Authorities, handling both local and global non-interventional cases.

We perform focused searches in relevant journals using trade names and active ingredients, followed by full-text reviews to identify and assess all reported ADRs and safety information for your products.

Periodic screening is customized to your SOPs and product volume, ensuring all direct CVD-reported adverse events are captured in your PV database, even those not spontaneously reported to your company.

Our AI-enabled tool automates Regulatory Authority website screening with machine-translation and validated keyword searches, delivering Health Canada-compliant signal validation and documentation.

Yes gain customized, transparent access to monitor the full case lifecycle, workflows, and KPIs, providing complete oversight of your safety data management.

Absolutely: Our GVP-compliant programs include comprehensive onboarding and periodic refreshers to equip your team for AE reporting and routine PV responsibilities, emphasizing that drug safety is everyone's role.

Compliance and Expertise

We ensure compliance with Health Canada GVP, alongside FDA and EMA standards, covering everything from aggregate reports to regulatory submissions for niche areas like oncology and rare diseases.
We start by listening to your needs, then conduct targeted assessments to identify PV gaps, developing coordinated, custom services—from single audits to full oversight for your unique setup.
Our bilingual Canadian experts manage PV for DINs, NPNs, medical devices, and advanced biologics, including case processing, risk-benefit evaluations, and inspection prep.
We believe in honest practices: Projects are timed precisely for efficiency, with no bait-and-switch clients benefit from clear, referral-driven value through our responsive, quality-focused approach.

Getting Started and Contact

Take our free 2-minute survey to assess PV readiness or audit gaps, then schedule a confidential discussion with a senior partner like Manar Hammood to explore your custom solution.
We'll review your inquiry within 24 hours, offering a no-obligation chat or demo—whether for ICSR support, trainings, or regulatory strategies—to align on your goals.
Yes—contact us to demo our validated safety database, AI monitoring tool, or training modules, tailored to your pharma challenges.
FREE CONSULTATION

Still Have Questions?
Start a conversation with a Zenith PV partner today.

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