Regulatory Strategy & Planning

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.

Benefit–Risk Assessment

A structured evaluation balancing a product’s benefits against its risks to support regulatory decisions and lifecycle actions.

Failure Modes and Effects Analysis(FMEA)

A risk analysis tool used to identify potential failure modes, their effects, and controls to reduce risk.

Fault Tree Analysis(FTA)

A top-down risk analysis method that models pathways leading to an undesired event to identify contributing failures and controls.

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Regulatory Strategy & Planning

Target product profile, indications, lifecycle strategy, and regulatory intelligence

10 terms

Applicant

The party submitting an application to a regulatory authority (e.g., NDA/BLA/MAA) and responsible for the submission and commitments.

Benefit–Risk Assessment

A structured evaluation balancing a product’s benefits against its risks to support regulatory decisions and lifecycle actions.

Failure Modes and Effects Analysis(FMEA)

A risk analysis tool used to identify potential failure modes, their effects, and controls to reduce risk.

Fault Tree Analysis(FTA)

A top-down risk analysis method that models pathways leading to an undesired event to identify contributing failures and controls.

Global Submission Strategy

A plan for sequencing and aligning submissions across regions, considering data readiness, regional requirements, timelines, and lifecycle changes.

Regulatory Intelligence

Systematic collection and analysis of regulatory information (guidelines, precedents, approvals, safety actions) to inform strategy and compliance.

Risk Assessment

A systematic process to identify hazards, estimate risk, and evaluate acceptability to support risk control decisions.

Scientific Advice

Regulatory feedback (often pre-submission) provided to support development planning, including evidence expectations and submission strategy.

Target Product Profile(TPP)

A strategic planning tool that summarizes desired labeling concepts and product characteristics to guide development and regulatory decisions.

Totality of Evidence

A regulatory concept where multiple lines of evidence (analytical, nonclinical, clinical) are integrated to support conclusions (e.g., biosimilarity, benefit–risk).