Quality Assurance
More than quality: An integrated approach to success
Spotting roadblocks before they become problems. Getting fast answers to questions, even those beyond Quality Assurance. Building strategies today that anticipate tomorrow’s challenges.
Our integrated model makes it all possible. It connects you to adjacent expertise — like logistics and regulatory strategy — reducing handoffs, increasing continuity, and eliminating surprises.
The result? Fewer delays. Smarter strategies. Greater success.
How we help
Quality Assurance and consulting services
Quality Consulting
Strengthen your quality systems. Or rely on us as your full-service Canadian quality unit.
- Manage regulatory licenses on your behalf
- Act as Canadian quality unit
- Develop tailored quality management systems
- Conduct quality assurance gap analysis
- Perform internal audits and self-inspections
- Prepare for audits and provide remediation support
- Host regulatory inspections
- Perform vendor audits
- Oversee manufacturers / packagers
- Provide interim in-house quality support
- Investigate deviations, complaints, OOS, and CAPAs
- Handle product release
- Manage backlogs (batch records, deviations, change controls, complaints, etc.)
- Qualify vendors (suppliers, QC laboratories, etc.)
- Draft and manage quality agreements
- Prepare APQR / YBPR
Audits
Navigate audits with confidence, backed by expert guidance.
- Conduct 21 CFR Part 210 and 211 (FDA GMPs)
- Support Health Canada GMPs for drugs, devices, and natural health products
- Address Health Canada GPPs for cannabis products
- Perform audits for medical devices (ISO 13485 MDSAP)
- Audit fabricators (pharmaceuticals, biologics, APIs, devices)
- Assess quality control laboratories Evaluate packagers and labelers
- Review distribution sites, 3PL, and importers
Importation, wholesale, and 3PL services
Simplify importation and ensure compliance with Health Canada licensing requirements.
- Prepare establishment licensing applications and amendments
- Act as importer of record
- Provide QPIC and product release support
- Release products to market with QPIC expertise
- Manage product complaint handling and recall processes
- Conduct self-inspections and audits
- Investigate quality issues and manage CAPAs
- Perform quality management reviews
- Conduct temperature mapping and validation
Training
Empower your team with customized training that builds expertise and readiness.
- Deliver GMP fundamentals and annual training
- Provide medical device fundamentals training
- Offer ISO 13485:2016 MDSAP training
- Prepare your organization for regulatory inspections
- Train on quality auditing and good documentation practices
- Navigate importation requirements with confidence
- Complete establishment licensing applications and amendments
Products we support
Rely on our multi-jurisdictional quality expertise for a wide range of product types, including:
- Active pharmaceutical ingredients (APIs)
- Pharmaceuticals
- Biologics
- Medical devices (ISO 13485, MDSAP)
- Natural health products
- Cosmetics
What sets us apart
At Innomar, quality never acts alone. By reducing handoffs and connecting adjacent expertise, we eliminate the silos that delay compliance activities, helping you move your product forward faster and with greater confidence.
Integrated model
Go beyond QA with access to regulatory, importation, and distribution expertise — all in one place.
Faster answers
Get guidance on crossover challenges without delays or scope limitations.
End-to-end insight
Build smarter strategies with a full view of your product’s journey.
Embedded in care
Minimize roadblocks with a team that’s deeply connected to Canada’s healthcare system.
Health Canada expertise
Gain insights from 55+ inspections and trusted relationships with Canadian regulators.
Proven systems
Stay ahead. Our processes evolve with Health Canada’s expectations, informed by 25+ years of audits and continuous improvement.
Canadian DEL advantage
Use our Drug Establishment License (DEL) to import and distribute your products. Or let us help you secure your own.
Flexible Support
Fill gaps for lean teams or scale up as your needs grow.
