BioBoston Consulting: One Stop Solution for Life Sciences
What Is an Investigational New Drug (IND) Application?
An IND application is a formal request submitted to the U.S. Food and Drug Administration (FDA) seeking authorization to begin human clinical trials with a new drug or biologic. This crucial application allows sponsors to legally ship and administer investigational compounds to clinical trial participants while the FDA reviews its safety and scientific integrity.
Key Elements of an IND Application:
- Preclinical (Nonclinical) Data: Includes pharmacology and toxicology in animal models to assess initial human safety.
- CMC (Chemistry, Manufacturing, and Controls): Documentation covering drug composition, production, stability, and quality control systems.
- Clinical Study Protocol: Describes trial design, endpoints, dosing regimen, safety monitoring, and inclusion/exclusion criteria.
- Investigator’s Brochure & Informed Consent: Summarizes all relevant preclinical/clinical data and ensures patient consent forms meet FDA/IRB standards.
- Administrative & Regulatory Documentation: Includes FDA Forms 1571 (IND), 1572 (Investigator Information), financial disclosures, and IRB approvals.
The FDA typically has 30 calendar days to review the IND; if there are no issues, clinical trials may proceed. Otherwise, a clinical hold is issued requiring resolution before trials can begin.
Why It’s Crucial for Clients to Engage This Service
Launching Clinical Development
An approved IND is mandatory to legally test new drugs in humans—without it, trials cannot begin.
Ensuring Safety, Scientific Integrity & Regulatory Compliance
A high-quality IND ensures that:
- Participant safety is prioritized,
- Manufacturing meets FDA quality standards, and
- Clinical protocols are scientifically and ethically robust.
Minimizing Risks & Delays
Emerging biopharma teams often face challenges like incomplete data, poor coordination between timelines, or lack of regulatory clarity—all of which can cause costly submission delays or clinical holds.
How Clients Benefit from BioBoston’s IND Application Service
- End-to-End IND Support
BioBoston provides full-spectrum assistance—from gap analysis and protocol design to document preparation, eCTD formatting, and FDA interaction. - Strategic Regulatory Guidance
Tailored advice aligned with each development stage ensures your IND is not only compliant but optimized for an efficient FDA review. - Integrated Preclinical & CMC Coordination
BioBoston ensures that your preclinical data and manufacturing timelines are synchronized—reducing risk of inconsistencies or submission errors. - FDA Meeting & Submission Readiness
The team helps you prepare for pre-IND meetings, navigates queries, and supports strategic responses to keep your submission on track.
Who Is Responsible for This Service?
BioBoston’s Regulatory Affairs & Clinical Strategy Team—composed of seasoned regulatory specialists, clinical scientists, and quality experts—is fully responsible for delivering the IND Application Service. Although no individual is named on the site, you can reach out to connect directly with the lead regulatory strategist or project manager.
Ready to Advance Your Drug Into Human Trials?
At BioBoston Consulting—One Stop Solution for Life Sciences, we help you navigate the IND process with expertise, precision, and speed. From data gap analysis to submission strategy, our team ensures your application is built for success.
Contact us today to initiate your IND journey—let’s get your investigational drug into clinical testing with confidence.