Site Audit Solutions

Stay confident in your compliance. Our site audit services help you meet Health Canada and FDA requirements for manufacturing, packaging, labeling, and distribution. We bring a fresh expert perspective to find gaps before regulators do and help you address them. 

Your Path To A Successful Site Audit Starts Here

A regulatory inspection can happen at any time, and even small oversights can have big consequences. These issues can arise from missed details in documentation, facility upkeep, or procedural steps that seem minor but impact compliance. 

With our guidance, you get a clear understanding of where your business stands, how to fix gaps, and how to improve systems so your operations run smoothly and meet regulatory expectations. We give you the tools and direction to protect your compliance and support the long-term success of your business. 

Our Site Audit Process

Pre-audit planning

We start by understanding your regulatory obligations and any recent changes so we can focus on the areas that matter most. 

We walk through your facility, reviewing equipment, processes, documentation, and how your team works day-to-day.

Together, we check SOPs, production and cleaning records, batch logs, and training files to confirm they are complete and accurate. 

You’ll get a clear report showing any gaps, their level of risk, and easy-to-follow steps to address them. 

We can help you put those fixes in place, update procedures, and prepare confidently for the next inspection. 

site-audit-process

Why A Site Audit Matters

A site audit helps you spot opportunities to strengthen compliance and efficiency long before an official inspection. Our audits give you a clear plan to meet regulatory expectations, enhance your processes, and support the ongoing success of your business. With it, you can: 

Align with GMP requirements
Ensure SOPs are accurate and up to date
Improve daily operations and workflows
Build a strong reputation with clients and regulators

Customized to Your Operations

No two facilities are the same. We tailor our approach based on: 

Why Work With Us?

18+ years in regulatory compliance
Audits led by experienced consultants
Actionable recommendations
Canadian and U.S. compliance experience
Support for corrective actions and follow-up

Frequently Asked Questions

A site audit is a proactive review conducted by our experts, not regulators. It is designed to identify strengths, uncover risks, and provide solutions before an official inspection takes place. 

For most facilities, we recommend an annual audit to maintain compliance and readiness. High‑risk operations, or those with frequent regulatory changes, may benefit from more frequent reviews.

We work around your production schedule and aim to keep any interruptions to a minimum. Most assessments can be completed with limited impact on daily workflows.

Absolutely. We help implement corrective actions, update or create SOPs, deliver targeted training, and guide you through any follow‑up requirements to ensure lasting improvements.

Yes. Our team performs audits based on Health Canada, FDA, and other international frameworks, tailoring each review to local regulatory requirements while maintaining global best practices.

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