Introduction
Many development teams create a Target Product Profile (TPP) early to align internal stakeholders and guide decision-making. However, during regulatory reviews and audits, we often see questions arise when the TPP is treated as a static planning document rather than a living regulatory tool. Regulators expect the TPP to evolve with development and to be clearly reflected in regulatory strategy, clinical design, and quality systems.
Why the TPP Matters to Regulators
Regulators view the TPP as a framework that connects scientific intent to regulatory execution. During audits and inspections, questions often focus on whether the TPP:
- Clearly defines the intended indication, population, and benefit–risk profile
- Informs critical development and regulatory decisions
- Remains consistent with submissions, protocols, and labeling strategy
When the TPP is poorly defined or outdated, inconsistencies tend to surface during reviews and audits.
What Regulators Expect to See in a Robust TPP
A well-defined TPP goes beyond high-level aspirations. Based on regulatory interactions and audit experience, regulators typically expect:
- Clarity and rationale for each proposed attribute, including endpoints and claims
- Alignment with development plans, clinical protocols, and CMC strategy
- Evidence of evolution, showing how the TPP has been updated as data emerges
- Traceability between the TPP, regulatory submissions, and quality commitments
Inspectors and reviewers assess whether the TPP genuinely guides development rather than merely documenting it.
Common Gaps Identified During Audits and Reviews
We frequently see regulatory and audit challenges when:
- The TPP is not revisited after early development decisions
- Clinical endpoints drift from original TPP assumptions without justification
- Regulatory commitments are not reflected into the TPP
- Quality and audit strategies are developed independently of the TPP
These gaps can raise questions about strategic alignment and regulatory control.
The Role of Audits in Supporting a Defensible TPP
Audits help ensure that the TPP is consistently applied across functions and partners. Effective audit programs can:
- Verify alignment between the TPP, clinical execution, and manufacturing plans
- Assess whether CROs and CDMOs are working to current TPP assumptions
- Identify inconsistencies early, before regulatory review or inspection
- Strengthen traceability between strategy documents and operational practice
Regulators expect organizations to demonstrate this level of internal alignment.
Integrating the TPP Into QMS and Regulatory Execution
A mature organization embeds the TPP into its broader QMS and regulatory framework. This includes:
- Using the TPP to inform risk assessments and change management
- Reflecting TPP updates in procedures, training, and documentation
- Incorporating TPP alignment checks into internal audits and management review
We often see fewer regulatory questions when the TPP is treated as an active control point.
How BioBoston Consulting Supports TPP Development and Alignment
BioBoston Consulting supports life sciences organizations in developing and maintaining well-defined, regulator-ready TPPs. Our services include:
- TPP development and refinement, aligned with regulatory expectations
- Regulatory and QMS alignment assessments, including audit readiness reviews
- Audit-driven verification, ensuring TPP assumptions are reflected in execution
- Lifecycle regulatory strategy support, from early development to commercial readiness
Our consultants bring hands-on regulatory, clinical, and audit experience, helping teams build TPPs that stand up to regulatory scrutiny.
A Question to Consider
If regulators reviewed your current development program today, would your TPP clearly explain why key decisions were made and how they are controlled?
If your Target Product Profile needs refinement or stronger alignment with regulatory strategy and QMS execution, BioBoston Consulting can help. We work with teams to strengthen TPP clarity, consistency, and audit readiness across the development lifecycle.
Connect with BioBoston Consulting to discuss building a regulator-ready Target Product Profile.