About Polaris Compliance Consultants

Founded in 1997, and located adjacent to the Research Triangle Park in North Carolina, Polaris offers consulting services to pharmaceutical and dietary supplement companies, contract research organizations (CROs), Institutional Review Boards (IRBs), and investigative sites and networks.

In an industry where the time to market for a product is so important, pharmaceutical and dietary supplement companies, CROs, IRBs, and research institutions all recognize that training new employees and maintaining the expertise of existing employees is critical. Quality Assurance audits provide valuable information to our clients, which helps them gauge their readiness for FDA inspections and next steps to market. SOP development and regulatory writing support our client’s processes to facilitate compliance with current regulations.

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Some of the advantages of using Polaris  include:

• Experienced personnel
  Polaris’  services are delivered by experts in various areas of the pharmaceutical and dietary supplement industries. Customers benefit from the broad experience gained by our staff as they worked in these industries. Our experienced auditors not only can identify issues, but can also advise the client on the level of significance of the finding and how best to address it. The experienced trainers can provide examples that are applicable to the audience and can answer questions whose answers so often begin with “it depends…”.
  Polaris has extensive experience performing compliance audits for FDA-regulated industries and utilizes the skills and experience of senior level technical consultants who are familiar with various FDA-regulated areas including pharmaceutical, dietary supplements, medical devices, and biologics.
• Commitment to quality
  It is Polaris’ policy to conduct internal reviews of projects and deliverables. For large projects, a Project Manager will oversee all phases of the audit process, ensuring a timely delivery of consistent, high-quality work products.
• Training program flexibility
  Training programs can be delivered at the client’s facility or through the internet. Standard or customized programs can be delivered to meet the specific training needs of the students and the budget requirements of the manager. With the option of online training, programs can be delivered cost effectively to staff at any location, saving travel and facility costs.