Services
GMP Training
Annual GMP training is a regulatory requirement, but it is most effective when it helps personnel understand how expectations apply in practice.
Compliant Approach provides GMP training that builds understanding by breaking down regulatory requirements and connecting them to day-to-day responsibilities, real-world examples, and case studies. Training may be offered as routine GMP education or tailored to the needs of the organization including role-specific sessions aligned with products, activities, and regulatory obligations.
This service is well suited to onboarding new staff, strengthening GMP awareness across the organization, and supporting more consistent application of GMP requirements.
GMP Audits
GMP audits provide an independent assessment of compliance and help identify gaps between written procedures, current practices, and regulatory expectations.
Compliant Approach provides internal audits, mock regulatory inspections, and focused reviews of specific systems or processes. Drawing on direct Health Canada inspection experience, audits are structured to highlight observations clearly and provide practical, actionable recommendations.
This service helps organizations understand where they stand, what requires attention, and where improvement efforts should be prioritized.
Inspection Readiness and Remediation
Inspection readiness is about more than documentation — it is about confidence, consistency, and disciplined execution. This service supports organizations before, during, and after regulatory inspections.
Support may include readiness assessments, targeted document and system reviews, interview preparation, and practical guidance on inspection conduct. During an inspection, Compliant Approach provides support in real time - helping organizations interpret requests, prepare accurate responses, and manage critical, time-sensitive issues as they arise. With experience on both sides of the table, support is informed by a sound understanding of the inspection process, regulatory expectations, and response strategy.
Where deficiencies or observations are identified during the inspection, the focus shifts to remediation that addresses the root cause, supports credible regulatory responses, and strengthens the site beyond the inspection itself.
Quality System Solutions
Strong quality systems do not come from interpreting requirements alone - they need to fit the organization, function in practice, and supports consistent execution.
Support may include SOP development and revision, quality system improvements, gap assessments, supplier qualification, data integrity, and broader support for regulatory and quality decision-making. Engagements are flexible and designed to complement internal respources while helping organizations build systems that are clear, workable, and aligned with regulatory expectations.
This service is well suited to organizations building quality systems from the ground up, strengthening current systems, addressing identified gaps, or navigating periods of change, growth, or increased regulatory complexity.
Natural Health Product Support
Natural health products marketed in Canada are subject to specific licensing and GMP requirements. Compliant Approach supports companies entering or operating in the Canadian NHP market with structured regulatory and quality guidance.
Support may include Product Licence Applications (PLAs), regulatory strategy, documentation required to market and sell products in Canada, and broad guidance on GMP expectations. Where appropriate, support may also include QAP-related oversight and quality support aligned for importers.
For organizations requiring site licensing support, services may include assistance with site licence applications and maintenance, development of compliant quality systems, inspection preparation, and implementation of GMP-compliant procedures.
Medical Devices Support
Medical device companies operate within a distinct regulatory and quality framework that requires clear systems, effective documentation, and ongoing compliance oversight. Compliant Approach provides practical support for organizations strengthening quality systems and navigating regulatory expectations in the medical device space.
Support may include ISO 13485 and MDSAP quality system support, gap assessments, internal audit, and broader guidance on quality and compliance requirements.