Support for Guidelines

• Bioanalytical Study Reporting
• FDA: Bioanalytical Method Validation, May 2018
• Immunogenicity Study Reporting
• FDA: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
• Data Integrity Requirements
• MHRA: ‚GxP‘ Data Integrity Guidance and Definitions
• FDA: Data Integrity and Compliance With Drug CGMP
• Upcoming ICH M10 guideline