What Is an Investigational New Drug (IND) Application?

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An Investigational New Drug (IND) application is a formal submission to the U.S. Food and Drug Administration (FDA), requesting approval to begin human clinical trials with a novel drug candidate. It includes:

• Preclinical data: animal studies demonstrating safety and pharmacology
• Chemistry, Manufacturing, and Controls (CMC): details on drug composition, manufacturing, and quality assurance
• Clinical protocols: study design, objectives, methodology, and investigator qualifications

Once filed, the FDA has 30 days to either place a hold or allow the trial to proceed—making the IND a critical legal and scientific gateway to clinical development.

Why Is the IND Application Important?

1. Regulatory Requirement You cannot lawfully conduct interstate clinical trials in humans without an approved IND—it is a mandatory first step.
2. Ensures Human Safety A thorough safety review protects participants, maintaining ethical and regulatory standards.
3. Facilitates Data Integrity With a clear IND, you can collect valid, FDA-acceptable data to support future submissions like NDA or BLA.
4. Speeds Development Expert-guided preparation reduces FDA questions, avoids clinical holds, and accelerates trial timelines.

How BioBoston Consulting Helps You Navigate IND

At BioBoston Consulting, we take a hands-on approach to streamline and strengthen your IND journey:

• Strategic Prep & Gap Analysis We review your preclinical and CMC datasets to identify any gaps before FDA submission.
• Dossier Assembly We organize documentation into a cohesive IND package—formatting per FDA guidelines.
• Clinical Protocol Support We assist designing safe, compliant, and scientifically robust protocols.
• FDA Engagement We serve as your liaison, addressing FDA inquiries promptly and accurately.
• Submission Management We oversee the entire process—from filing within 30-day deadlines to managing regulatory holds, if necessary.

This end-to-end support minimizes roadblocks and empowers you to launch trials confidently.

Who Leads the IND Process?

Successful IND submissions require a team effort, led by:

• Regulatory Affairs Manager – Oversees the entire IND submission and FDA communications
• Preclinical / CMC Team – Provides critical safety and manufacturing data
• Clinical Research Team – Designs and writes the clinical trial protocol
• Quality Assurance Unit – Ensures all documents comply with GCP, GxP standards
• Legal Counsel – Reviews agreements and informed consent forms

Our internal team at BioBoston mirrors this structure, seamlessly integrating these roles for smooth execution.

Ready to Launch Your IND?

Do not let regulatory complexity derail your clinical ambitions. Partner with BioBoston Consulting to optimize your entire IND application.

Contact BioBoston Consulting today to benefit from our comprehensive IND support designed to help your drug candidate enter human trials safely, swiftly, and compliantly.