How Start-Up Biotechs Can Set Themselves Up for IND Success

You’ve got promising preclinical data and a lead candidate with real potential—but before you can begin clinical trials in the U.S., you need to file an Investigational New Drug (IND) application with the FDA. For many start-up biotech companies, this is the first major regulatory milestone and often the first interaction with the Agency.

The good news? With proactive planning, the right cross-functional support, and a sound digital infrastructure, you can navigate the process confidently. Here's how to set yourself up for IND success.

IND Success Tip 1: Assemble the Right Team Early

Even if you're lean, it’s essential to bring in cross-functional experts who understand both science and FDA expectations. At a minimum, you’ll need:

• A Regulatory lead who can interpret guidance and manage communications with FDA

• CMC (Chemistry, Manufacturing, and Controls) expertise to oversee drug substance and drug product development

• Nonclinical experts to ensure your animal studies meet FDA standards (e.g., GLP compliance)

• A Clinical lead to design your proposed first-in-human trial

• Quality assurance support, even part-time, to ensure compliance from the start

• Digital/IT Strategy consulting to ensure your systems are ready to support your science and regulatory needs

You don’t need a full-time team for each of these areas, but you do need access to the right people. Many start-ups successfully engage experienced consultants to fill gaps.

➡️ The Sugar Water Operations Team partners with emerging biotechs to provide this kind of specialized regulatory support—strategically brought in just when you need it most.

IND Success Tip 2: Plan for a Pre-IND Meeting

The Pre-IND meeting is your chance to get FDA feedback on your development plans before you submit your IND. It's especially useful for:

• Clarifying the adequacy of your nonclinical safety data package

• Confirming your proposed clinical trial design is appropriate

• Discussing any CMC or formulation questions

• Asking about any novel aspects of your product

Preparing for this meeting involves drafting a briefing package, submitting a meeting request, and carefully framing your questions to FDA. A strong Pre-IND interaction can prevent costly delays later.

We often advise clients to integrate regulatory timelines with IT planning—including how they’ll store, access, and submit key documents. You don't want your FDA meeting prep delayed because you can't locate a finalized tox report or submission-ready protocol – and getting your IT strategy in place now means you’ll be audit-ready in the future.

IND Success Tip 3: Understand What Belongs in Your IND Submission

An IND is more than just a cover letter and a protocol. It must include:

• Module 1: Administrative information and forms (e.g., FDA Form 1571, 1572, and cross-referenced letters if needed), Investigator's Brochure

• Module 2: Summary documents

• Module 3: Quality information (CMC)

• Module 4: Nonclinical study reports (e.g., pharmacology, toxicology)

• Module 5: Clinical protocol and investigator/site documents

All documents must be formatted according to the eCTD (electronic Common Technical Document) specifications. If you’re not already working in eCTD format, you’ll need to plan for that early—submissions must be in eCTD to be accepted by FDA.

💡 With over 20 years of experience in RegOps and eCTD Publishing, coupled with our Project Management and Digital/IT Strategy services, we can help ensure your content lifecycle—from authoring through submission—is efficient, compliant, and audit-ready.

IND Success Tip 4: Line Up Your GLP and GMP Compliance

FDA expects your nonclinical toxicology studies to be performed under Good Laboratory Practice (GLP) conditions. They also expect that your clinical trial materials will be manufactured under Good Manufacturing Practice (GMP) conditions. This means:

• Vetting your CROs and CMOs for compliance

• Having written protocols and procedures

• Ensuring proper documentation and data integrity practices are followed

It’s common for start-ups to outsource these functions, but you’re still responsible for oversight. Having a well-documented digital quality system—even a lightweight one—can make this easier.

IND Success Tip 5: Develop a Realistic Timeline (With Buffer)

IND preparation often takes longer than expected. Build in time for:

• Pre-IND interactions (typically 2–3 months for the full process)

• Document drafting, review, and quality control

• eCTD publishing and final checks

• Responding to potential FDA feedback after submission

A common misstep is underestimating how long it takes to finalize and QC every document in the IND package. Give your team the time they need to get it right.

IND Success Tip 6: Be Prepared for FDA’s 30-Day Review Clock

Once you submit your IND, FDA has 30 calendar days to review it. They may:

• Allow the trial to proceed (no communication needed)

• Request additional information (an Information Request, or IR)

• Place the IND on clinical hold

The best way to avoid a clinical hold is to anticipate questions and address them proactively in your submission. Having your regulatory and nonclinical leads do a pre-submission "health check" of the IND can catch red flags before FDA does.

IND Success Tip 7: Don’t Forget Your FDA Communication Setup

To submit documents and communicate with FDA, you’ll need to get two things in place ahead of time:

• Secure Email with FDA: Your designated regulatory contact or sponsor representative must complete the setup process. This can take several business days.

• ESG NextGen / Unified Submission Portal Account: You must submit your IND and any pre-IND materials via the Unified Submission Portal (USP). This requires account registration, validation, and test submissions to ensure your setup is compliant with FDA's eCTD standards.

📢 Our team at The Sugar Water Operations Team not only handles your eCTD publishing—we also provide strategic digital support to make sure your systems, user roles, and workflows are ready for these interactions from day one.

IND Success Tip 8: Track and Archive Everything

From IND submission to all FDA correspondence, keep clear, organized records. This is not only a best practice—it’s essential for:

• Responding to FDA questions quickly

• Ensuring continuity as your team grows

• Supporting future submissions (e.g., IND amendments, meeting requests)

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And if you're not sure how or where to store all that correspondence, we can help you stand up simple, compliant, scalable systems that make version control, audit trails, and access management effortless.

Final Thoughts

Submitting your IND is a major milestone, but it doesn't need to be overwhelming. With careful planning, the right partners, and a clear understanding of what FDA expects, your start-up can confidently make the leap from preclinical promise to clinical development.

Need Help?

At The Sugar Water Operations Team, we specialize in helping small and emerging biotech companies navigate early regulatory milestones—including IND planning, eCTD submissions, FDA correspondence, and now, Digital/IT Strategy Services tailored to growing teams.

We’ll help you build the tech foundation that supports your regulatory goals—without overbuilding or overspending.

👉 Contact us or sign up for our newsletter to get practical insights and tools for your next big step.