Pre-NDA Meetings - Techsol Life Sciences

Regulatory Affairs Services

Pre-Submission Meeting: NDA

Pre-NDA Meeting

A Pre-NDA (New Drug Application) Meeting is a formal, Type B interaction between a sponsor and the U.S. FDA, typically held prior to submitting an NDA. This meeting provides an opportunity for sponsors to obtain FDA feedback on the overall data package, regulatory strategy, and submission readiness to support marketing approval.

Scope of Pre-NDA Meeting

The scope of a Pre-NDA meeting includes alignment on late-stage development outcomes, regulatory expectations, and submission details across the following areas:

Clinical Data Review: Discussion of pivotal trial results, safety and efficacy endpoints, and statistical analysis plans
CMC and Quality: Review of drug substance and drug product manufacturing, stability, and control strategies ensuring compliance with regulatory standards
Labeling Strategy: Early input on proposed product labeling, claims, and risk mitigation plans
Regulatory Pathway: Confirmation of submission format, expedited programs (e.g., Priority Review, Fast Track), and post-approval commitments
FDA Feedback on Potential Gaps: Identification of deficiencies that could delay filing acceptance or approval
Submission Format and Content Expectations: Guidance on eCTD structure, module completeness, and data presentation

Key Elements of a Pre-NDA Meeting

Strategic Planning & Gap Assessment

Internal reviews to assess pivotal data readiness and regulatory compliance
Regulatory intelligence gathering on FDA expectations and precedent cases

Meeting Request Submission

Formal submission of the meeting request to the relevant FDA review division via the CDER or CBER NextGen Portal

Briefing Package Development

Authoring a comprehensive Pre-NDA briefing package in CTD format, including:

Product overview and clinical development summary
Summaries of clinical efficacy, safety, and CMC data
Specific, targeted questions for FDA feedback

Question Strategy & Risk Prioritization

Developing clear and focused questions to clarify FDA expectations and reduce uncertainty
Organizing questions by clinical, CMC, labeling, and regulatory topics for efficient discussion

Meeting Logistics & Coordination

Scheduling and coordinating teleconference, written response, or in-person meetings
Ensuring participation of key cross-functional stakeholders

Meeting Execution Support

Preparing speaker notes and conducting internal rehearsals
Managing real-time FDA interactions and note-taking

Post-Meeting Documentation & Action Plan

Consolidating meeting minutes and analyzing FDA feedback
Incorporating feedback into final NDA submission plans and timelines

How Techsol Enables Pre-NDA Meeting Success

Techsol Life Sciences delivers end-to-end support to maximize the value of Pre-NDA meetings:

Regulatory Intelligence & Gap Analysis – Evaluating clinical and CMC data readiness, identifying risks that may impact NDA acceptance or approval timelines
Briefing Package Development – Crafting detailed, FDA-compliant briefing books in CTD format with clear presentation of clinical and quality data
Question Strategy – Formulating targeted questions to obtain critical FDA guidance on pivotal trials, labeling, manufacturing, and regulatory pathways
Meeting Logistics Management – Handling meeting request submissions and scheduling via FDA portals, tracking progress, and managing deadlines
Sponsor Preparation & Meeting Readiness – Providing thorough pre-meeting coaching, role-play Q&A, and strategic alignment for successful FDA interactions
Post-Meeting Follow-Up – Delivering concise meeting summaries, interpreting FDA feedback, and developing actionable plans for timely NDA submission