To promote business continuity and compliance with regulatory guidelines, we offer a comprehensive line of validation, compliance, and quality services to clients. Our team of subject matter experts is well versed on the most up-to-date guidance from the FDA and can bring a practical understanding of interpretations required to mitigate risk enterprise-wide.
Capabilities cover the full range: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, Part 58, and across the entire spectrum: CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment/utilities/facilities, process/cleaning/packaging.
Engineering design qualification services include:
For more information, contact:
Daniel RhodesPhone:: (760) 458-4505E-mail:: firstname.lastname@example.org
Michael RuchmanPhone:: (858) 232-7110E-mail:: email@example.com
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