What is a regulatory submission?
A regulatory submission contains the clinical, non-clinical, and manufacturing data needed to support approval of a pharmaceutical product. It is submitted to agencies such as the FDA, EMA, or PMDA, and may include modules for quality, safety, efficacy, and risk management.
Why are regulatory submissions important in drug development?
They represent a critical milestone for bringing a therapy to market. The quality, clarity, and completeness of the submission directly influence approval timelines and outcomes. Cross-functional alignment and early planning are essential to ensure submission success and downstream access.
