For emerging biopharma companies, preparing an Investigational New Drug (IND) application is a critical step toward initiating clinical trials in the United States. The IND submission process is complex, highly regulated, and often unfamiliar territory for early-stage teams. Understanding the key FDA requirements for IND applications is essential to avoid delays, clinical holds, or costly rework.
In this guide, we break down the core components of a successful IND application and explain how BioBoston Consulting can help your company navigate the process with confidence and speed.
What Is an IND Application?
An IND application is the formal request submitted to the U.S. Food and Drug Administration (FDA) to begin clinical testing of a new drug or biologic in humans. The IND serves to protect the rights and safety of human subjects while ensuring the investigational product is manufactured and tested under proper standards.
The FDA reviews three key areas:
- Animal pharmacology and toxicology data
- Manufacturing information (CMC – Chemistry, Manufacturing, and Controls)
- Clinical protocols and investigator details
Once approved, the sponsor may begin Phase 1 clinical trials in the U.S.
Core IND Application Requirements for Emerging Biopharma Teams
- Preclinical (Nonclinical) Data
The FDA requires a robust preclinical data package to demonstrate that the drug is reasonably safe for first-in-human (FIH) trials. This includes:
- GLP-compliant toxicology studies in two species
- Pharmacokinetics (PK) and pharmacodynamics (PD) data
- Safety pharmacology and genotoxicity testing
This section helps the FDA determine if the proposed clinical trial poses an acceptable risk to participants.
- CMC (Chemistry, Manufacturing, and Controls)
Your IND must include detailed CMC documentation to show that the investigational drug can be manufactured consistently and safely. This includes:
- Drug substance and product composition
- Manufacturing methods and controls
- Stability data
- Analytical procedures and specifications
Emerging biopharma teams should align CMC timelines with toxicology studies to avoid submission delays.
- Clinical Study Protocol
This section outlines your clinical trial design and objectives. Key elements include:
- Inclusion/exclusion criteria
- Dosing strategy and schedule
- Study endpoints and statistical plan
- Safety monitoring procedures
An unclear or incomplete protocol is a common reason for FDA comments or holds.
- Investigator’s Brochure & Informed Consent
The Investigator’s Brochure (IB) summarizes nonclinical and clinical data relevant to the investigational drug. Informed consent forms must clearly communicate study risks, benefits, and patient rights.
- Administrative and Regulatory Documents
Submit the following:
- Form FDA 1571 (IND Application)
- Form FDA 1572 (Investigator Information)
- Financial disclosure forms
- IRB approvals (if already obtained)
Common Challenges for Emerging Biopharma Companies
Many early-stage companies face challenges such as:
- Limited in-house regulatory experience
- Incomplete preclinical or CMC packages
- Uncoordinated timelines across functions
- Difficulty preparing for pre-IND meetings or FDA feedback
These issues can lead to submission delays or even clinical holds if not addressed early in the development process.
How BioBoston Consulting Helps You Meet IND Requirements
At BioBoston Consulting, we provide end-to-end regulatory support to help emerging biopharma companies succeed in filing high-quality IND submissions. Our expert consultants offer:
- Regulatory strategy and timeline alignment
- Gap analysis of preclinical and CMC data
- Clinical protocol development and review
- IND document preparation and eCTD formatting
- FDA meeting support and response planning
We act as an extension of your team, ensuring your IND application is not just complete, but also strategically optimized for FDA review.
Accelerate Your IND with Expert Support
Getting your first IND application right is critical to starting clinical trials on time and building investor confidence. Let BioBoston Consulting help you avoid costly setbacks and achieve regulatory success.
Contact BioBoston Consulting today to schedule a consultation and move forward with confidence on your path to first-in-human trials.