Regulatory and procedural guidelines
READ MORE Regulatory and procedural guideline: D80 assessment report - Overview guidance rev. 6.16
READ MORE Regulatory and procedural guideline: D80 assessment report - Clinical guidance rev. 3.16
READ MORE Regulatory and procedural guideline: Day 80 assessment report - Quality guidance
READ MORE Regulatory and procedural guideline: D80 assessment report - Non-clinical guidance rev. 3.16
READ MORE Regulatory and procedural guideline: D80 assessment report - Non-clinical guidance rev. 3.16
READ MORE Regulatory and procedural guideline: Day 80 assessment report overview guidance - generics rev. 3.16
READ MORE Regulatory and procedural guideline: Day 80 assessment report generics quality guidance rev. 3.16
READ MORE Regulatory and procedural guideline: Day 80 assessment report non-clinical and clinical guidance - generics rev. 3.16