AI-Accelerated Regulatory Submissions.
Expert-Validated Results.

CentaurAI™ combines advanced AI drafting with DHCG’s deep regulatory expertise to deliver faster, higher-quality IND authorship

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ABOUT CENTAURAI

Manual IND Authorship Puts Your Critical Timeline at Risk

Demands Focus:

In-house IND authorship pulls development teams away from activities supporting asset development and preparation for clinical trials

Extends Timelines:

Manually collating source materials, validating data quality, and module authoring, often result in a months long process - putting your critical path at your risk

Risks Rework:

Top-quality regulatory submissions that avoid the risk of clinical hold or receiving information requests require highly experienced ex-FDA regulatory expertise, which is often unavailable in-house or in other 3rd party reviewers

Available February 2026

Let CentaurAI Overcome the Challenges of Manual IND Authorship

CentaurAI™ merges the speed of large language models with the uncompromising quality standards of Dark Horse Consulting.

AI-Accelerated Authorship

CentaurAI efficiently compiles and processes source files to rapidly generate your IND, drastically reducing timelines to submission

AS FEW AS

3 WEEKS

TO SUBMISSION-READY IND
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ABOUT CENTAURAI

Human-in-the-Loop Validation

IND quality is fully validated by DHCG’s world class regulatory team whose track record includes 120+ regulatory submissions across novel biotherapeutic modalities

Outsourcing IND authoring to CentaurAI allows your team to focus on reaching critical program milestones

How It Works

A seamless integration of AI precision and expert human oversight
with privacy and security built in throughout.

1

Preparation

  • Initial engagement to ensure preparedness
  • Source materials are provided and reviewed
  • Remediation of any gaps in source materials
2

Authorship

  • CentaurAI generates the draft IND modules
  • DHC experts refine and polish the full IND draft
  • Full expert review by ex-FDA reviewers for quality & completeness
3

Finalization & Submission

  • Client reviews & feedback are incorporated
  • The completed IND is published in eCTD format
  • Optional: Dark Horse Consulting will submit the IND on your behalf

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About CentaurAI

Confidentiality Commitment: DHC treats all client data as strictly confidential. Your information will not be shared, sold, or disclosed to third parties unless we have received your express written consent or are required to do so by applicable law.

Data Handling FAQ