IND, NDA, & BLA Authoring
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IND, NDA, & BLA Authoring

The Core of Your Regulatory Journey

Overview

The submission of an IND, NDA, or BLA is a monumental milestone. We provide end-to-end management of these critical applications. Our team of medical writers, regulatory strategists, and publishers work in unison to produce a high-quality, scientifically cohesive dossier that tells the story of your drug's safety and efficacy.

Key Features

Module 1-5 authorship and compilation
Integrated Summary of Safety/Efficacy (ISS/ISE)
Clinical Study Report (CSR) writing
Submission project management

Our Process

1

Kick-off & Planning

Establishing the timeline, TOC, and resource plan.

2

Content Creation

Iterative drafting and review of all submission components.

3

Finalization

Quality control, publishing, and transmission to the FDA.

Project Complete & Deliverables Provided

Frequently Asked Questions

An IND (Investigational New Drug application) allows you to begin clinical trials in humans—it's required before Phase 1 studies. An NDA (New Drug Application) is what you submit after clinical trials to get marketing approval for small-molecule drugs. A BLA (Biologics License Application) serves the same purpose as an NDA but is for biological products like monoclonal antibodies, vaccines, and cell therapies.

Why Choose Us

  • Cohesive scientific narrative
  • Reduced review times
  • Minimized technical rejection risk
  • Full team alignment

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
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We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for IND, NDA, & BLA Authoring.

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What Our Clients Say

"Our NDA was a massive undertaking with 18 clinical studies. Adelphi's project management kept 40 contributors on track, and we filed on schedule. The FDA accepted our submission without any filing issues."

Dr. Robert Chen

SVP Regulatory Affairs

Mid-Size Pharma

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