Parallel development planning for drug-diagnostic codevelopment per FDA guidance, including PMA vs. 510(k) pathway selection, breakthrough designation strategies, and timing alignment with therapeutic BLA/NDA submissions.

Prospective-retrospective study design for CDx clinical validation, with statistical analysis plans demonstrating analytical validity, clinical validity, and clinical utility that satisfy FDA/EMA requirements for companion diagnostic claims.

Accuracy, precision, sensitivity, specificity, and reproducibility studies for IVD assays, with FDA-compliant protocols for LOD/LOQ determination and clinical cutoff validation in intended-use patient populations.

QMS establishment for diagnostic manufacturers meeting both ISO 13485 (device) and GMP (if applicable) requirements, with process validation, reagent qualification, and stability protocols supporting commercial-scale production.

Development of diagnostic intended use statements and biomarker interpretation guidance that align with therapeutic labeling, addressing FDA's expectation for harmonized drug-diagnostic patient selection criteria