Compliance Auditing

Both domestically and abroad, companies are continually challenged to achieve and maintain regulatory compliance. You need to qualify your vendors, prepare for inspections by regulatory authorities, visit at-risk or under-performing facilities and sites, and verify that staff is adequately trained, following procedures, and producing/maintaining quality data.

Polaris’ regulatory experts have conducted audits across 23 countries and 5 continents. We deliver timely, thorough, and well-written audit reports. You can always expect a clear explanation of audit findings, their significance to your company, and our recommendations for resolving them. Afterwards, Polaris can provide Remediation Assistance and help you develop and implement your CAPA plan.

Audit Types

GCP	GMP Pharmaceuticals

GLP	GMP Dietary Supplements

CSV / Part 11

Preparing Data and Documents for FDA Audits

Data & Docs

Audit Categories

Routine Audits
to ensure that you, your sites, and your vendors are compliant with regulations
For Cause Audits
to determine the root cause of unusual, incorrect, or suspicious activities, results, or circumstances
Vendor Qualification Audits
to evaluate the capabilities and quality systems of prospective vendors and out-sourcing partners
Validation Audits
to ensure your systems are 21 CFR Part 11 compliant and have undergone sufficient validation
Inspection Readiness Audits
to identify and resolve non-compliances in advance of a visiting regulatory agency
Due Diligence Audits
to evaluate the quality systems in support of merger and acquisition decisions

About Polaris Compliance Consultants

Founded in 1997 and located adjacent to the Research Triangle Park in North Carolina, Polaris provides consulting services to pharmaceutical, biotech, medical device, and dietary supplement companies, IRBs, Investigative sites and networks, CROs, manufacturers, and other contract organizations. Our clients span 5 continents, ranging in size from very small to very large.

We offer Quality Assurance services, including audits and document review, to help our clients gauge their inspection readiness, evaluate suppliers, and determine next steps to market. We provide writing, training, and consulting services to give our clients the expertise that they may not have in-house and temporarily extend the capabilities of their valued staff.

Why Should You Select Us?

We’re experienced
Our services are delivered by experts with extensive backgrounds in the pharmaceutical, device, and dietary supplement industries. In fact, several members of our auditing team are former FDA inspectors.

Our products and services are tailored and sized for your company
Our auditors not only identify issues, but will talk to you about the significance of the findings and how best to address them. Our trainers can provide examples that are applicable to your staff and can address questions whose answers so often begin with “it depends…”

We’re committed to the quality of our work
We conduct internal reviews of all projects and deliverables. Project Managers oversee and follow the progress of your project activities, ensuring a timely delivery of consistent, high-quality work products.

In August 2017, We Turned 20

(And This Is Us!)

This is home base, but we have consultants all over the world.
Call us and we can provide you the expertise you need, where and when you need it.

The Raleigh Skyline

Auditing