201 Strykers Road, Suite 19-246
Lopatcong, NJ 08865
Telephone: 908.285.2714
E-mail: michelle.hicks@redsummitconsulting.com

The Red Summit Compliance staff has over 20 years of experience in FDA-regulated industries through its consultants. These consultants have successfully established and maintained ISO-certified and FDA-compliant quality and clinical systems in the medical device and In Vitro Diagnostic fields.

Red Summit can work with your organization to address your FDA compliance needs and to ensure processes meet all necessary regulatory requirements. Experience in medical devices/IVDs qualifies us to assist you with Quality System compliance, FDA regulations, FDA QSIT audits, cGMPs, FDA inspections and responses.

Our Compliance Services deliver consistent and effective results. We provide strategic approaches to address your specific business needs and provide creative, efficient solutions that will align with your organization.

Red Summit's industry-trained consultants can assist in the implementation of new quality systems or improvement of existing quality systems:

Red Summit Consulting will provide:

The compliance branch of Red Summit has worked with organizations ranging in size from start-ups to Fortune 500 companies to establish and maintain ISO-certified and FDA-compliant quality management and clinical affairs systems in the medical device and In Vitro Diagnostics fields.

The software implementation team focuses on implementing and validating EtQ brand Quality Management System software following best-in-class GAMP methodologies.

The Clinical Trial Services division provides clinical trial protocol development, study monitoring, and study management services for trials conducted worldwide (North America, Europe, Asia and Africa).

For more information about Red Summit Consulting, please contact us via e-mail: michelle.hicks@redsummitconsulting.com

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