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 Consulting
- 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
QA consultants: Easing entry into the Canadian market
A QA consultant can be a valuable resource when bringing a drug to the Canadian market. Hear from Brian Randall, Director, Quality Assurance, how QA consultants help you with critical steps from applying for a drug establishment licence to becoming your importer of record. With the experience of over 55 Health Canada inspections, our team has the expertise you can trust to guide you.
The information provided in this piece does not constitute legal or medical advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.
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
- Active pharmaceutical ingredients (APIs)
- Pharmaceuticals
- Biologics
- Medical devices (ISO 13485, MDSAP)
- Natural health products
- Cosmetics
