Patero is a Montréal firm that helps pharmaceutical, natural health product and cosmetics companies validate their computer systems, strengthen quality assurance and manage regulatory affairs, in English and French.
Our team combines deep industry expertise with practical, hands-on support tailored to your needs.
Patero is a Montréal firm that combines computer system validation, quality assurance and regulatory affairs under one roof, so your systems, procedures and filings stay consistent with each other.
We work in English and French, and we stay involved until the document is accepted or the inspection is closed.
Validation, quality, regulatory affairs and AI governance from one team, so your systems, procedures and filings stay consistent with each other.
We validate the computerized systems of pharmaceutical companies and manufacturers of drug products (DIN) against Health Canada, FDA and European requirements. We combine deep GxP expertise with modern validation practices, including Validation 4.0 principles, to make validation more efficient, practical, and sustainable.
Bringing a product to market? We help pharmaceutical, natural health product, and cosmetics companies navigate Canadian regulatory requirements, from product classification and Health Canada submissions to labelling compliance. We also support quality systems, inspection preparation, and ongoing compliance.
Use AI without putting your compliance at risk. We help regulated companies set up governance frameworks, document their AI systems, and define who reviews and approves what, inside the quality system you already have.
We serve pharmaceutical, natural health product and cosmetics companies, and other regulated sectors, from first filing to ongoing compliance.
Computer system validation, quality systems and GMP compliance for drug manufacturers and distributors.
Support for Canadian market entry, NPN submissions, quality, and inspection readiness.
Health Canada cosmetic notifications, labelling and regulatory compliance for products sold in Canada.
Working in another regulated sector? Tell us about your needs and let's explore how we can help.
“Patero helped us navigate the Canadian regulatory landscape with clarity and confidence. Their practical approach made a complex process much easier for our team.”
Clear answers to common questions from regulated businesses.
What is computer system validation (CSV)?
Computer system validation (CSV) is the documented process of demonstrating that a computerized system performs as intended and is suitable for its use in a regulated environment. It typically involves defining requirements, assessing the system’s impact on regulated activities, testing relevant functions, and maintaining evidence throughout the system’s lifecycle. The scope of validation depends on the system, its intended use, and the applicable regulatory requirements.
What is Validation 4.0?
Validation 4.0 is a modern approach to validation that emphasizes critical thinking, efficient use of evidence, and activities proportionate to a system’s intended use and impact. Rather than producing documentation for its own sake, the goal is to focus effort where it adds value while maintaining appropriate control and traceability. It can include making better use of supplier documentation, automation, and existing system knowledge.
What is required to bring a natural health product to market in Canada?
The requirements depend on the product, its ingredients and claims, and the activities your business performs. They may include obtaining a product licence and Natural Product Number (NPN), meeting applicable site-licensing requirements, preparing compliant labels, and establishing appropriate quality processes. Identifying the right regulatory pathway early can help clarify what must be in place before launch.
How can a company prepare for a Health Canada inspection?
Inspection preparation starts well before an inspector arrives. Companies should ensure that procedures reflect actual practices, records are complete and accessible, and employees understand their responsibilities. Reviewing previous observations, assessing gaps, and following through on corrective actions can also help a team demonstrate how its quality system works in day-to-day operations.
Whether you're preparing to launch a product, validating a critical system, or looking for ongoing quality support, we're here to help.
