Regulatory development involves extensive documentation, complex evidence, and competing deadlines. I combine scientific and regulatory expertise with AI-assisted workflows to help teams prepare, organize, and review information more efficiently.
My goal is to shorten document turnaround times, reduce repetitive work, and identify potential errors earlier—with expert review and accountability throughout.
I help teams organize relevant guidance, agency feedback, and development evidence around a defined regulatory question.
AI assists with information processing; I assess the underlying sources, applicability, and implications for your program.
Support may include:
What you receive: Source-linked summaries that distinguish established requirements, recommendations, and issues needing further assessment.
I use AI-assisted methods to organize source materials, develop document outlines, and support initial drafting. Each draft is reviewed for scientific accuracy, context, and alignment with the agreed purpose.
Support may include:
What you receive: Structured drafts, source references, and a clear list of items requiring clarification or expert input.
Information can become inconsistent when multiple teams prepare different sections of a submission. I use AI-assisted comparison alongside expert review to flag discrepancies and coordinate their resolution.
Support may include:
What you receive: A reviewed discrepancy log and practical recommendations for improving document consistency and completeness.
CMC information often spans development reports, specifications, stability summaries, and manufacturing records. I help organize this evidence and identify issues that need technical or regulatory assessment.
Support may include:
What you receive: Structured CMC summaries, flagged inconsistencies, and questions for technical follow-up.
I use AI-assisted workflows to organize evidence, consolidate cross-functional input, and support meeting preparation.
Support may include:
What you receive: Organized preparation materials and reviewed drafts that support a clear, consistent company position
I help teams identify where AI can add value within their existing regulatory processes and where human judgment must remain central.
Support may include:
What you receive: A practical workflow plan, defined responsibilities, and a basis for deciding whether to expand its use.
1. Define the need
Agree on the task, source materials, deliverables, and measures of success.
2. Establish safeguards
Confirm appropriate tools, access controls, and permitted use of client information.
3. Apply AI selectively
Use AI to support defined tasks such as organization, drafting, extraction, or comparison.
4. Review and resolve
Check outputs against source materials and apply scientific and regulatory judgment.
5. Evaluate the benefit
Assess turnaround time, review effort, rework, and the quality of findings.
AI-generated content can contain inaccuracies or miss important context. I review AI-assisted deliverables before delivery and involve the appropriate technical specialists when needed.
Confidential client information is used only within agreed tools and data-handling arrangements.
AI supports my work; regulatory recommendations remain grounded in evidence and professional judgment.
Shorter document preparation and review cycles.
Less time spent on repetitive manual tasks.
Earlier identification of potential inconsistencies and omissions.
More organized evidence and clearer follow-up actions.
More time for scientific assessment and strategic decisions.
Benefits depend on the task, source quality, and review requirements. AI-assisted preparation does not determine agency review timelines or approval outcomes.
Have a submission approaching, a complex CMC package, or a document review process that needs improvement?
Start with a focused discussion about your workflow and where AI-assisted support could make a practical difference.