Compliance Consultants - Auditing

To ensure that both you and your vendors are compliant with regulations and guidelines, Polaris auditors can review your existing audit plan and provide you with advice, or create a customized audit plan for you. These Clinical Research consulting services cross a wide variety of specialties and facilities, including Sponsors, CROs, study sites, IRBs, non-clinical labs, manufacturing facilities, and data.

The audit reports you receive from us will be timely, thorough, and well-written, clearly documenting any non-compliance issues and recommendations. If you need help rectifying any compliance shortfalls identified during the audits, Polaris can assist you in the CAPA process and also offers Remediation Assistance.

Vendor Qualification Audits allow you to evaluate the quality and controls of prospective vendors and out-sourcing partners.

Inspection Readiness or Pre-Inspection Audits (PIAs) prepare you for formal inspections by regulatory agencies. Identifying and resolving areas of non-compliance in advance of a regulatory inspection can save your company considerable time and resources. Our professional auditors have experience with domestic and international regulatory agencies, and keep current with industry trends. In fact, several members of our auditing team are former FDA inspectors.

For-Cause Audits can be conducted to determine the root cause of unusual, incorrect, or suspicious activities, results, or circumstances.

Routine Compliance Audits can ensure that you, your sites, and your vendors are compliant with regulations.

Follow-up Audits, normally conducted on an annual or semiannual basis, ensure that regulatory compliance is maintained over time.

Additional Clinical Research Consulting is available to assist you with project-specific needs, such as responding to a 483 or implementing a CAPA system.
 

Polaris Audit Specialties: