Independent GMP Auditing & Compliance Solutions
Mitigate regulatory risk. Validate supply chain integrity. Ensure audit readiness.
Why Choose Us?
We tailor our approach to meet each client’s unique goals, ensuring compliance and minimizing risks. With a team of regulatory experts and industry professionals, we provide clear strategies and insights to navigate regulations, empowering you to grow your business confidently.
Objective Perspective
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We provide an unbiased view that internal teams often miss
Regulatory Expertise
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Deeply knowledgeable in current industry standards and enforcement trends
Actionable Reporting
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We don't just list problems; we provide clear context to help you prioritize remediation
Ready To Get Started?
FAQ & Process Overview
Planning to elevate your compliance strategy?
Our Audit Services
We tailor our scope to meet specific regulatory frameworks (Health Canada, FDA, ISO) and your internal quality standards.
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Supplier & Vendor Qualification: Verify that your raw material and packaging suppliers meet your quality requirements and regulatory obligations.
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Internal Mock Audits: Simulate a regulatory inspection to identify weaknesses and train your staff on audit etiquette.
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Gap Analysis: A targeted review of your Quality Management System (QMS) against current GMP regulations.
For-Cause Audits: Investigation-driven audits to address specific quality failures, OOS results, or complaints.
While internal audits are essential, they can suffer from familiarity bias. A third-party auditor provides an objective, unbiased assessment of your Quality Management System (QMS). Furthermore, regulatory bodies (such as Health Canada and the FDA) view independent audits as a strong indicator of a proactive quality culture and diligent vendor oversight.
We tailor our audit criteria based on your target market and product type. We routinely audit against:
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Health Canada: Food and Drug Regulations (Part C, Division 2 for Drugs; Part 3 for NHPs).
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US FDA: 21 CFR Part 210/211 (Pharmaceuticals) and Part 111 (Dietary Supplements).
ISO Standards: ISO 13485 (Medical Devices) and ISO 9001.
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Yes. While on-site audits provide the most comprehensive view of facility conditions, we offer robust remote auditing (desktop audits) for document review and initial vendor qualification. This is a cost-effective solution for lower-risk suppliers or when travel is restricted.
You will receive a formal audit report within 7 business days of the closing meeting. This includes:
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Executive summary of compliance status.
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Detailed observations classified by risk (Critical, Major, Minor).
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References to the specific regulatory clauses violated.
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Recommendations for remediation.
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The Audit Process
We utilize a transparent, four-step methodology to ensure minimum disruption to operations while maximizing thoroughness.
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Pre-Audit Planning
We define the audit scope, agenda, and applicable standards (e.g., 21 CFR, ICH, NHP Regulations) with your team
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Execution
Comprehensive review of facilities, equipment, personnel, and documentation (SOPs, batch records, validation protocols)
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Reporting
You receive a detailed audit report within7 business days, categorized by risk level (Critical, Major, Minor)
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Post-Audit Aid
We assist in reviewing Corrective and Preventive Actions (CAPA) to ensure root causes are effectively addressed
Ready to Get Started? We help you navigate these steps efficiently to ready your audit
See What Your Certification Looks Like
Sample of Health Canada VHP Licence
Regulatory Compliance Experts
Providing regulatory solutions across Canada & internationally.
Bringing your products to market with confidence.
Client Support: (+1) 647-975-3819
Email: info@fullscopereg.com
© 2025 by Full Scope Compliance Solution Ltd
