Regulatory Services

Compliance Consulting

FDA regulatory compliance, EU regulations, and recommendations are all areas in which our regulatory domain specialists and affiliate consultants have extensive experience. We offer quality assurance and services related to 21 CFR Part 11 as well as fake FDA inspections, GCP, GMP, GLP, and PV audits. Thanks to the global distribution of our professionals, we are prepared to satisfy the complex demands of our clients in all their auditing operations around the world. Audits have been performed in both Eastern and Western Europe, as well as in Australia, New Zealand, Russia, China, Asia, Canada, Mexico, South America (Chile, Argentina, and Brazil), Latin America, the Caribbean, India, Japan, Israel, and the United States.

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