Investigational New Drug Applications

From promising science to clinical reality

Preparing an IND isn’t just a regulatory requirement. It’s a pivotal step in the life of your program. It’s where science meets strategy, and where the strength of your team matters most.

At inSeption Group, we understand what’s on the line. We’ve helped numerous emerging and midsize biotechs navigate the complexities of IND planning, authoring, and submission. Our teams bring the scientific fluency, regulatory insight, and operational know-how needed to present your asset with confidence—and clear the path to your first-in-human trial.

A successful IND doesn't start at submission.

It starts with a smart, integrated plan.

inSeption aligns scientific understanding, regulatory expertise, and writing precision from day one, so your IND is both compelling and compliant.

Whether you're starting from scratch or refining what’s already in motion, we guide you through:

  • Strategic planning and timelines
  • Regulatory pathway evaluation
  • Document gap analysis and remediation
  • Authoring, QC, and publishing
  • Communication with the FDA

IND support

Regulatory Strategy and Operations

  • IND development plans and timelines
  • FDA meeting support and briefing documents
  • Cross-functional coordination and readiness
  • eCTD publishing and regulatory operations

Medical Writing and Documentation

  • Module 2 and 3 summaries
  • Nonclinical and clinical overviews
  • Protocols and investigator brochures
  • Safety narratives and risk management plans
  • QC and document formatting

Functional Integration

Therapeutic Expertise

Your IND should make a statement.

Let’s work together to get it right and set the tone for the rest of your clinical journey.

Dive deeper

Schedule quality time today.