Investigational New Drug Applications

From promising science to clinical reality

Preparing an IND isn’t just a regulatory requirement. It’s a pivotal first milestone towards marketing authorization and patient benefit. 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 scientific fluency, regulatory insight, and operational expertise needed to position your asset with confidence, clearing 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
• Authorship and Quality Control (QC) of regulatory submission documents
• Communication with the FDA
• eCTD submissions to FDA through ESG Gateway

IND support

Regulatory Strategy
• IND strategy, development plans and timelines
• FDA meeting support and briefing documents
• Cross-functional coordination and readiness

Regulatory Affairs
• Navigation of regulatory requirements and health authority interactions to ensure alignment with global standards

Regulatory Operations
• Oversight of technically compliant submissions to FDA

Medical Writing and Documentation
• Module 2 and 3 summaries
• General Investigational Plan
• Protocols and investigator brochures
• Risk:Benefit summaries
• QC and document formatting

Pre-IND Submission Training
• Clear overview of the IND process, key components, and critical timelines
• Insight into FDA expectations, communication pathways, and common pitfalls
• Strategic tips for navigating pre-IND meetings and information requests
• Practical preparation tools—checklists, templates, and scenario-based discussion
• Real-time Q&A and coaching with inSeption experts who’ve led successful INDs

Functional Integration
• Clinical operations planning
• Vendor oversight and study start-up coordination
• Biostatistics support and SAP development
• TMF structure and regulatory documentation alignment

Therapeutic Expertise
• Rare/orphan disease
• Oncology
• Neurodegenerative disorders
• Cell therapy
• Gene therapy

Your IND is a statement of intent.

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.