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Target product profile, indications, lifecycle strategy, and regulatory intelligence
10 terms
The party submitting an application to a regulatory authority (e.g., NDA/BLA/MAA) and responsible for the submission and commitments.
A structured evaluation balancing a product’s benefits against its risks to support regulatory decisions and lifecycle actions.
A risk analysis tool used to identify potential failure modes, their effects, and controls to reduce risk.
A top-down risk analysis method that models pathways leading to an undesired event to identify contributing failures and controls.
A plan for sequencing and aligning submissions across regions, considering data readiness, regional requirements, timelines, and lifecycle changes.
Systematic collection and analysis of regulatory information (guidelines, precedents, approvals, safety actions) to inform strategy and compliance.
A systematic process to identify hazards, estimate risk, and evaluate acceptability to support risk control decisions.
Regulatory feedback (often pre-submission) provided to support development planning, including evidence expectations and submission strategy.
A strategic planning tool that summarizes desired labeling concepts and product characteristics to guide development and regulatory decisions.
A regulatory concept where multiple lines of evidence (analytical, nonclinical, clinical) are integrated to support conclusions (e.g., biosimilarity, benefit–risk).