IND, NDA & BLA Publishing
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IND, NDA & BLA Publishing

From First-in-Human to Full Approval

Overview

Whether you're filing your first IND to begin clinical trials or submitting a complex NDA/BLA for marketing approval, proper eCTD compilation is essential. Our publishing team specializes in FDA submissions across the full development lifecycle. We understand the specific requirements for different submission types and ensure your documents are organized, linked, and formatted to facilitate efficient FDA review.

Key Features

Initial IND and IND amendments/supplements
Original NDA/BLA submissions
Efficacy supplements and labeling changes
Annual reports and periodic safety updates
Pre-submission packages (Type A/B/C meetings)
Promotional material submissions

Our Process

1

Submission Planning

We review your submission requirements and establish a publishing timeline aligned with your target date.

2

Content Coordination

We work with your team to ensure all documents are received, reviewed, and ready for publishing.

3

eCTD Compilation

We compile documents into the proper CTD structure with appropriate hyperlinking and formatting.

4

Validation & Submission

We validate the package and either deliver for your submission or transmit directly via FDA Gateway.

Project Complete & Deliverables Provided

Frequently Asked Questions

An IND includes Module 1 (administrative information and prescribing information), Module 2 (summaries), Module 3 (quality/CMC data), Module 4 (nonclinical study reports), and Module 5 (clinical study protocols and available clinical data). Initial INDs are typically smaller than NDAs, but proper structure is still essential for FDA review.

Why Choose Us

  • Expertise across all FDA submission types
  • Proper sequence numbering and lifecycle management
  • Understanding of FDA-specific requirements
  • Efficient handling of large clinical data packages
  • Reliable, on-time delivery for your filing dates

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
Request Information

We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for IND/NDA/BLA Submissions.

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What Our Clients Say

"Adelphi handled our NDA publishing during a very compressed timeline. Despite having to process over 400,000 pages of clinical data, they delivered on time and the submission sailed through FDA's filing review. Outstanding work."

Dr. James Wilson

VP Regulatory Affairs

Mid-Size Pharma

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