Canadian expertise for your Pharmacovigilance, Quality and Regulatory functions
We are a Canadian company that helps life-science teams meet Health Canada requirements in pharmacovigilance, quality and regulatory affairs, using validated digital tools through an entirely qualified Canadian team.
Founded on trust
Pharmacovigilance (PV)
We provide end-to-end PV operations in Canada, including notification of foreign actions, literature and regulatory authority database (CVD) screening, aggregate reports and signal management, and GVP inspections and audits support.
Precision in Compliance
Regulatory Affairs (RA)
We offer due-diligence and submission strategy, drug life-cycle management, labelling updates and eCTD publishing, and medical writing to ensure seamless regulatory compliance and market success in Canada and beyond.
Excellence Assured
Quality Assurance (QA)
We provide importer/distributor QMS setup, batch release and deviation management, product technical complaints (PQC) handling, GMP audits and CAPA, eQMS implementation and validation, and vendor qualification to ensure robust quality assurance and GxP compliance across your operations.
Innovation Validated
Digital Solutions
We deliver validated digital tools that reduce errors and accelerate decisions, along with database migration and management, screening automations with human QC, SOP version control, and audit readiness packages to streamline compliance and enhance operational efficiency.
WELCOME TO ZENITHPV
Working with Zenith
Build the system. Run the work. Pass inspections. Achieve Compliant RatingWhat you get: Defined outputs. Documented methods. Commitment to timelines. Evidence you can show an inspector. How we work: Clear scope. Transparent Process. Fully informed. Rapid response and full accountability Pricing model: Transparent, Competitive, Long-term partnership driven. Fixed or retainer model
Trusted by Global Companies
GMP Inspection readiness achieved in four weeks for a mid-size MAH.
Canada Vigilance reconciliation established for 50 products with weekly cadence.
Importer QMS implemented with 24 SOPs and training attestations in 60 days.
OUR SOLUTIONS
Who we Serve
We proudly serve market authorization holders (DIN, NHP, Medical Devices), importers, distributors, and Canadian and global biotech and pharma teams—delivering boutique, compliant pharmacovigilance and regulatory solutions that scale with your ambition, from local startups to international innovators, with the same nimble expertise and unwavering trust.
Data that drives decisions.
Aggregate Reporting Expertise
Navigate Health Canada & FDA GVP with our bilingual qualified PV professionals to author aggregate reports with in-depth critical analysis for early detection of early safety signals.
PROCESS
How to Get Started
Through detailed discussions and research, we gather the insights needed to craft a tailored solution that aligns with your vision.
Assess Your PV Readiness in Minutes
Take our quick, confidential survey to spot gaps in your drug safety setup or audit prep. It's free, takes under 2 minutes, and gives you instant insights plus, flag if you'd like a chat.
Connect with a Senior Partner
Jump on a call with one of our senior partner. We listen to your story, understand your pharma challenges (from biologics to devices), and brainstorm a custom fit.
Launch Your Bespoke Solution
We craft and kick off your plan, whether it's audits, aggregate reports, or full regulatory strategy. Watch compliance click into place while you get back to innovating.
Book A Discovery Call
Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
Expertise
Custom Compliance Strategies
Our philosophy begins with listening to your unique needs, allowing us to craft boutique regulatory and compliance solutions that are as distinctive for your success. From conducting thorough gap analyses to providing comprehensive RA, PV & QA support. Zenith tailors every aspect whether it's new drug submission strategy, product re-launch, PV compliance gap assessment or QMS implementation. This personalized approach ensures not just compliance with Health Canada, FDA, and EMA standards, but also builds lasting confidence in your products, turning potential challenges into efficient, and reliable outcomes.
NimbleExpertise
RegulatoryMastery
ClientTrust
Proactive Risk Insights
Spot trends early to turn PV risks into strategic safeguards for your treatments.
Gap Analysis Quick-Start
Uncover compliance gaps in 2 minutes get free, actionable fixes fast.
Data-Driven Safety Insights
Reveal safety patterns with data analysis for sharp risk-benefit calls.
English 
French