Pre-BLA Meetings - Techsol Life Sciences

Regulatory Affairs Services

Pre-Submission Meeting: BLA

Whether you’re submitting a traditional biologic, a novel gene therapy, or participating in an expedited review program, Techsol ensures your Pre-BLA meeting is focused, well-documented, and strategically aligned with FDA’s expectations.

Accelerate Biologic Approvals with Techsol’s Pre-BLA Meeting Expertise

Pre-BLA Meetings – Overview

At Techsol Life Sciences, we support biopharma innovators in planning and executing Pre-BLA (Biologics License Application) meetings that pave the way for regulatory success. These critical Type B meetings with the U.S. FDA are designed to confirm the adequacy of your data, the structure of your submission, and any remaining concerns prior to filing a BLA.

Pre-BLA Meeting

A Pre-BLA (Biologics License Application) Meeting is a Type B formal interaction between a sponsor and the U.S. FDA held prior to the submission of a BLA. It serves as a critical regulatory checkpoint where sponsors confirm the completeness, quality, and format of their application and address any remaining agency concerns.

At Techsol Life Sciences, we guide sponsors through Pre-BLA preparations with strategic, technical, and documentation support to de-risk the submission, clarify FDA expectations, and accelerate regulatory review timelines—especially for complex products like biologics and gene therapies.

Scope of a Pre-BLA Meeting

The Pre-BLA meeting focuses on ensuring that the sponsor’s final submission package aligns with FDA requirements. Its scope includes:

Verification of Application Completeness: Confirming that all required data (CMC, clinical, safety) will be included
Discussion of Clinical Efficacy & Safety Results: Key findings, pivotal trial data, and safety profiles
Review of CMC Data: Manufacturing processes, comparability, analytical validation, and product release testing
Labeling Strategy & Content Plan: USPI, prescribing information, REMS (if applicable), and carton/container labeling
Electronic Submission Format: eCTD readiness, structure, and technical file validation
Post-Marketing Requirements: Plans for pharmacovigilance, risk mitigation, and post-approval commitments
Expedited Program Considerations: Eligibility or ongoing designation under Fast Track, Priority Review, Breakthrough Therapy, etc.

Key Elements of a Pre-BLA Meeting

Strategic Planning & Gap Assessment

Identification of submission readiness status and regulatory gaps
Review of development timeline, fast-track status, and review designation eligibility

Meeting Request Submission

Preparation and formal submission of a Pre-BLA meeting request to CDER or CBER, depending on product type

Briefing Package Development

Authoring a CTD-formatted briefing package, including:

Overview of product, indication, and development history
Summaries of pivotal clinical trials, safety data, and CMC readiness
Specific questions for FDA review and clarification

Targeted Question Strategy

Prioritized queries related to:

Data sufficiency
Labeling expectations
Post-marketing study requirements
Submission format or missing modules

Meeting Logistics & Coordination

Coordination of teleconference or face-to-face meeting
Cross-functional team alignment (Regulatory, Clinical, Safety, CMC)

Meeting Execution Support

Preparing internal stakeholders with speaker scripts and response plans
Capturing notes and clarifications during the FDA interaction

Post-Meeting Follow-Up

Consolidating FDA feedback and meeting minutes
Developing an action plan to address feedback before final BLA submission
Updating submission timeline, format, and content as needed

How Techsol Enables Pre-BLA Meeting Success

A well-executed Pre-BLA meeting can significantly streamline your submission process and avoid last-minute regulatory challenges. Techsol supports the full meeting lifecycle:

Pre-Meeting Strategy & Risk Identification – Early planning and data readiness assessments to ensure your development program is aligned for BLA submission.
Meeting Request Management – Submission of formal meeting requests to CDER or CBER, with correct categorization and timelines.
Briefing Book Development – Preparation of high-quality, CTD-formatted briefing packages addressing clinical, CMC, safety, labeling, and post-marketing topics.
Targeted Question Development – Framing of strategic questions to confirm submission completeness, formatting alignment, and regulatory expectations.
Meeting Logistics Coordination – Scheduling and managing FDA teleconferences, face-to-face discussions, or written responses.
Post-Meeting Documentation & Follow-Up – Capturing formal meeting minutes, aligning submission plans with FDA guidance, and managing follow-up actions.

Value proposition

Proven Experience with Complex Biologics & Gene Therapies – We support advanced product submissions requiring in-depth FDA dialogue and clarification.
Integrated Regulatory, CMC & Clinical Expertise – Our team brings a 360° view of BLA data requirements to deliver complete and compelling briefing content.
Accelerated Submission Readiness – We identify and address potential roadblocks early—streamlining your timeline to filing and review.
Strategic FDA Alignment – Our experts ensure your submission format, content, and timeline align with FDA feedback to reduce the risk of review delays.
Expedited Program Insight – Support for programs under Fast Track, Priority Review, RMAT, or Orphan Drug Designation to maximize review advantages.