Compliance Insight has been helping companies, large and small, with their regulatory compliance and quality assurance challenges since 2000. Our dedicated team has over 150 years of combined knowledge and experience in FDA-regulated industries.
Cynthia Ipach, President of Compliance Insight, Inc., founded the company in 2000 after working 15 years in the pharmaceutical industry. She began her career in Analytical Research and Development and later moved into Regulatory Affairs. As her career progressed she held the following titles: Assistant QA Manager, QA/RA Manager and Director of Scientific Affairs. Cynthia is currently serving FDA-regulated industry as a consultant on regulatory, quality, and compliance issues. She has expertise in US and international regulatory filings, project management, strategic planning, GMP auditing, GAP analysis, validation planning, training, and compliance assistance. Cynthia is a member of the Gerson Lehrman Council of Healthcare Advisors.
Troy Fugate. With approximately 20 years industry experience and as the Vice President of Compliance Insight, Inc., Troy works with companies nationally and globally in the pharmaceutical and biotechnology industries in the fields of Compliance and Quality Assurance. He has expertise in parenteral, tablet, capsule, oral liquid and API regulation compliance. His consulting realm includes FDA, EU, DEA, etc. regulation compliance. Troy’s primary strengths are Quality Assurance activities with emphasis in quality systems, validation, risk assessment and systemic audits. Troy has performed many professional presentations at various conferences and conducts training on topics associated with compliance and quality. Troy’s professional affiliations include ASQ, IVT, PDA, and ISPE. He is an editorial board member for the Journal of GXP Compliance and an expert committee member for the Journal of FD&C. Click here to learn more about Troy.
