Quality Assurance (QA)
We build, run and improve pharmaceutical quality systems for the Canadian market. Our work covers importer and distributor requirements, GMP activities, document control and computer system validation so that records stand up to Health Canada review.
EXPERTISE
Unmatched Compliance with Canadian Good Manufacturing Practices
We support Biologics, prescription medicines, OTCs and natural health products. We work with importers, distributors, manufacturers and remote license holders that need Canadian coverage.
OUR SOLUTIONS
Our Core QA Services
Our essential QA offerings emphasize proactive risk mitigation and inspection readiness, adaptable to your requirements under Health Canada's GMP framework.
- Quality manual, procedures and templates sized to your license and product mix
- Document control and training records with version history
- Release controls, change control and deviation management with CAPA follow-through
- Review of manufacturing and packaging records for compliance and data integrity
- Product Quality Review with actions, owners and timelines
- Deviation, OOS and investigation support to enable compliant release
- Internal audits and vendor audits with gap lists and corrective actions
- Preparation for Health Canada inspections, including evidence packs and interview notes
- Training for teams on roles, records and responses
- Intended use, risk assessment, traceability and test evidence for eQMS and other tools in scope
- Change control and periodic review of validated systems
- Secure exchange of validation artefacts
- SOPs, work instructions and quality agreements with bilingual outputs when required
- Controlled forms, logs and checklists you can present to inspectors
- Archive and retrieval that shows what changed, when and why
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Book A Discover Call
Book a discovery call with a Zenith PV senior partner today to discuss your needs, uncover gaps, and kickstart your compliance journey.
How we work
Our QA services integrate seamlessly with pharmacovigilance, regulatory affairs, and medical information, ensuring end-to-end compliance from audits to submissions. Rooted in our values of trust and ownership, this approach provides direct senior access and transparent practices that build lasting client partnerships.
Clear scope
Clear scope with a plan, owners and dates
Defined outputs
Procedures, records and evidence organised for inspection
Canadian Team
All work performed in Canada by a Canadian team
Bilingual Services
Bilingual (En/Fr) delivery available
Typical starting points
Gap Review
A short gap review before an audit or inspection
QMS/SOP Setup
Importer or distributor QMS/SOP set-up with core procedures and training
Deviation & CAPA
Deviation and CAPA clean-up with a focus on release and data integrity
English 
French