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Our team is comprised of seasoned medical professionals, ex-FDA inspectors, and Fortune 500 Quality, Regulatory, and Compliance executive managers, we bring over 85 years of combined experience to the table. Our expertise spans clinical research, design controls, and manufacturing quality systems, catering to organizations ranging from small startups to Fortune 50 organizations including contract manufacturers and in-house producers.

We’re proud to be established authors for PharmaVoice, Pharma Online, Pharmaceutical Engineering, Medical Device and Diagnostics, and the Drug Information Association. Our commitment to process excellence is underscored by our commitment to industry best practices monitoring/reporting and active participation in the ASQ and RAPS communities. Recognized by Fortune 500 companies for our innovative approaches in quality management systems design, evaluation, and improvement, we remain dedicated to advancing quality and compliance in the Life Science industry.

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