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Bioanaltyical method development and validation services are conducted in compliance with the United States Food & Drug Administration (FDA), Guidance for Industry Bioanalytical Method Validation (21 CFR Part 58) and in accordance with Custom Biologics' Standard Operating Procedures. Pharmaceutical testing, bio-analytical method validation and data analysis are conducted under GLP regulations according to FDA guidelines (21 CFR Part 58), 21 CFR Parts 11 and 58 Compliant
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