Pre-Submission Meeting : Pre-IND Meeting, Pre-NDA Meeting & Pre-BLA Meeting

Regulatory Affairs Services

Pre-Submission Meeting: IND

We assist in Pre-NDA meetings by reviewing pivotal trial data packages and submission plans to meet FDA expectations on efficacy, safety, and labeling. For biologics, we provide comprehensive support for Pre-BLA meetings, addressing clinical, manufacturing, and regulatory requirements critical to successful Biologics License Application filings.

Overview

At Techsol Life Sciences, we possess extensive experience supporting clients in preparing and managing Pre-IND, Pre-NDA, and Pre-BLA meetings with the FDA to ensure efficient drug development and regulatory approval. Our expertise includes guiding sponsors through early Pre-IND meetings to align nonclinical, CMC, and clinical strategies, thereby minimizing the risk of clinical holds.

Pre-IND Meeting

A Pre-IND (Investigational New Drug) Meeting is a formal, Type B interaction between a sponsor and the U.S. FDA, typically held before submitting the first IND application. This meeting allows sponsors to obtain early regulatory guidance on their nonclinical, clinical, and CMC (Chemistry, Manufacturing, and Controls) plans.

Scope of Pre-IND Meeting

The scope of a Pre-IND meeting encompasses early-stage regulatory strategy, development plan validation, and FDA engagement across the following areas:

Clinical Development Plans: Discussion of first-in-human trial design, endpoints, patient population, and dose selection
Nonclinical Data Requirements: Assessment of toxicology studies, pharmacology plans, and bridging data
CMC Readiness: Review of manufacturing controls, analytical methods, stability data, and comparability strategy
Regulatory Pathway Clarification: Confirming the appropriate IND pathway and any expedited designations (e.g., Fast Track, Orphan Drug)
FDA Feedback on Gaps or Risks: Early identification of issues that could delay IND acceptance or trial initiation
Clarification of Submission Format and Expectations: Including eCTD structure, module organization, and content completeness

Key Elements of a Pre-IND Meeting

Strategic Planning & Gap Assessment

Internal readiness reviews to identify development gaps and prioritize discussion points
Regulatory intelligence gathering based on precedents, FDA guidance, and product class

Meeting Request Submission

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

Briefing Package Development

Authoring a well-structured Pre-IND briefing package (in CTD format) including:

Product overview and development rationale
Summaries of CMC, nonclinical, and clinical data
Specific, targeted questions for FDA feedback

Question Strategy & Risk Prioritization

Framing of clear, concise questions to clarify regulatory expectations and minimize ambiguity
Grouping questions by topic (CMC, nonclinical, clinical) for structured discussion

Meeting Logistics & Coordination

Scheduling the meeting (teleconference or written response only)
Ensuring participation from key cross-functional stakeholders

Meeting Execution Support

Preparing speaker notes, internal rehearsals, and managing FDA discussions
Real-time note-taking and clarification during the meeting

Post-Meeting Documentation & Action Plan

Consolidating meeting minutes
Analyzing FDA feedback and incorporating it into the development strategy
Establishing timelines and deliverables for IND submission

How Techsol Enables Pre-IND Meeting Success

We approach each Pre-IND meeting as a key regulatory milestone that can drive smarter, faster development decisions. Our support includes:

Regulatory Intelligence & Gap Analysis – Assessment of development plans and identification of risks and gaps in your clinical, nonclinical, and CMC strategies.
Briefing Package Development – High-quality authoring of FDA-compliant briefing books in CTD format, including background, study plans, and rationale.
Question Strategy – Targeted question development to obtain FDA feedback on trial design, safety studies, manufacturing controls, and regulatory classification.
Meeting Logistics Management – Complete coordination of the meeting request and timelines via FDA’s CDER NextGen Portal, with Type B meeting tracking.
Sponsor Preparation & Meeting Readiness – Support for teleconferences, written responses, or face-to-face meetings with role-play Q&A and strategy alignment.
Post-Meeting Follow-Up – Consolidation of meeting minutes, interpretation of FDA feedback, and development of a strategic action plan for IND readiness.