About Zenith
Zenith is a Canadian-owned and operated GxP services company. Our work is delivered entirely in Canada by an experienced team that operates pharmacovigilance, quality, and regulatory functions for life-science organisations. We pair day-to-day operations with validated digital tools so that files stand up to Health Canada review.
What we do
Our RA services seamlessly integrate with pharmacovigilance, ensuring submissions incorporate robust safety data from aggregate reports and audits. This holistic approach, rooted in our core values of trust and ownership, delivers compliant outcomes that enhance physician preference and brand loyalty.
Pharmacovigilance (PV)
Intake, case processing, medical review, Canada Vigilance submissions, aggregate reporting, inspection readiness
Quality Assurance (QA)
Importer and distributor QMS set-up and operation, SOP suites and training, vendor qualification, audits and CAPA, computer system validation and eQMS implementation.
Medical information (MI)
Bilingual (English and French) medical information call center (MICC) support, streamlined identification of AEs and PQS, metrics and KPIs reports.
Regulatory Affairs (RA)
Due diligence and submission strategy, DIN life-cycle management, labelling updates, RMP adaptations, responses to authority queries, planning for inspections and information requests.
How we Work
We keep scope clear and outputs defined. Every engagement has documented methods, version-controlled templates, and evidence you can show an inspector. We work with your team in a way that fits your size and stage, from targeted fixes to steady-state operations.
Why Canada matters here
All work is performed in Canada by Canadian staff. That means fluency with Health Canada expectations, practical knowledge of local processes, and straightforward data handling under Canadian privacy law. We do not offshore.
Quality and privacy
Quality is built into our delivery. We operate with a written quality system, risk-based planning, and routine internal checks. Privacy is handled with care: access is limited, training is mandatory, and data flows are documented. Where digital tools are in scope, validation artefacts are available on request.
Our Ethos
We value clear writing, simple processes, and reliable delivery. We favour evidence over opinion and publish checklists and guidance that clients can use immediately. We hire people who know the work, teach the details, and keep records that make audits uneventful.
What we achieved
Principles That Power Partnerships
Our team includes qualified pharmacovigilance leads, quality specialists, regulatory managers, and experienced medical writers. You will know who is responsible for your project and how to reach them.
Where we operate
We support Canadian and international market authorisation holders, importers, distributors, and emerging biotechs that need Canadian coverage. Services are available in English, French and Spanish.
Getting Started
Most clients begin with one of three paths
Speak to us
Choose the path that fits or send documents securely and we will respond with next steps.
Founder & Director of PV Operations
Manar Hammood
Leads client relationships and delivery quality. With 10+ years in Canadian and International life sciences across pharmacovigilance, medical affairs, quality and regulatory operations. Former head of PV & QA for multiple MAHs. Canadian GMP and GVP opinion leader, sought after speaker and panelist in Canadian and Global consensus and educational forums. Change maker, Woman leader, Spirited Entrepreneur.
Pharmacovigilance Operations Team
A core team of dedicated, bilingual professionals with a combined experience of 25 years run the Canada PV operations end to end, including intake, medical review oversight, Canada Vigilance submissions and aggregate reporting. Built inspection-ready case workflows for portfolios with >100 DINs. Qualifications include PharmD; MD, MD PhDs and Advanced life science degrees.
Quality Assurance Team
PV Our growing QA team implements and operates importer and distributor QMS systems. We author SOP suites, trains teams, run internal audits and CAPA, and manage supplier qualification. Experienced in computer system validation for regulated tools for Devices & Drugs.
Regulatory Affairs
Our newest senior team manages DIN life-cycle activities, labelling updates, RMP adaptations and responses to Health Canada information requests. We coordinate dossier changes and oversee submission calendars.
Digital & CSV capabilities
We have the inhouse capability to design validated tools that support and underpin our PV, QA and RA work. This includes risk assessment and traceability through IQ, OQ and PQ. Data protection, release controls, training scripts for in-scope software are offered as part of our services.
Advisory Panel
We work with Senior Canadian specialists and former Health Canada inspectors in pharmacovigilance, quality and regulation who review complex files and readiness plans. Profiles will depend on the degree of complexity.
Industry Experiences
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Hub IT allows your business and technology computers to store, transmit, analyze, and manipulate big data.
Hub IT allows your business and technology computers to store, transmit, analyze, and manipulate big data.
Trusted by global brands
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