If you need a road map or help along the way, we can help.

Renowned for their expertise and depth of experience, our consultants are in high demand worldwide. With more than half of our consultants being ex-FDA experts we are especially suited for consulting the FDA regulated industries on many of the urgent matters you are facing.

We can work on-site with you to develop or improve numerous GMP or Quality System areas. We bring expertise to such areas as document control, CAPA, auditing, management review, validation, laboratory controls, training and complaint handling. Our product expertise lies in medical devices, including IVDs and pharmaceuticals.

Our consultants can assist you in reviewing or writing a Compliance Master Plan or any other document that is important to GMP or quality system compliance. Whether the project involves setting up a CAPA or management review program, a complete gap analysis, process mapping, scorecard, or the establishment of a validation master plan, we are ready to assist your organization.

Furthermore, we can provide project management staff on site to assist in implementation of compliance projects. We can add strength to areas where your organization may have a weakness. It is not our goal to enter into lengthy consulting projects, but rather to get you involved in establishing and maintaining an adequate and effective quality system. We want to get you going in a manner that is not dependent on consultants. Yet often that jump-start is needed in many areas of the quality system. We will work with your staff to get you going and, as soon as possible, leave you alone to do your job.

To discuss possible on-site consulting initiatives please contact us today! Please visit our Connect page to contact us.