Investigational New Drug (IND) Application Services: Your Gateway to Clinical Trials

One Stop Solution for Life Sciences

For pharmaceutical and biotechnology companies, moving from preclinical research into human testing is a defining milestone in drug development. The Investigational New Drug (IND) Application is the formal regulatory request submitted to the U.S. Food and Drug Administration (FDA), granting authorization to administer investigational drugs to humans in clinical trials.

At BioBoston Consulting, we specialize in guiding life sciences organizations through this critical process—making us your trusted One Stop Solution for Life Sciences.

What Is an IND Application?

An IND Application is a regulatory submission to the FDA that authorizes both the initiation of human clinical trials and the interstate shipment of investigational drugs.

An IND must include three essential components:

• Preclinical Data – Laboratory and animal study results demonstrating drug safety for first-in-human use.
• Manufacturing Information – Full details on composition, manufacturing methods, quality controls, and stability testing.
• Clinical Protocols & Investigator Information – Study design, objectives, methodologies, and qualifications of the investigators responsible for trial execution.

Once submitted, the FDA has 30 days to review the IND. If no objections are raised, the IND becomes effective, and human clinical trials can begin.

Why Is the IND Application Critical for Life Sciences Companies?

1. Mandatory Legal Authorization
   An approved IND is legally required to begin human trials and transport investigational drugs across state lines.
2. Patient Safety & Scientific Integrity
   The FDA evaluates preclinical data to ensure human subjects are protected from unnecessary risk.
3. Foundation for Development Success
   IND approval serves as the gateway to Phase I, II, and III clinical trials, ultimately supporting New Drug Application (NDA) approval.
4. Investor & Partner Confidence
   A successful IND submission demonstrates regulatory readiness and credibility to stakeholders.

How IND Applications Benefit Clients

• Structured Development Roadmap
  Provides a clear, stepwise pathway from preclinical testing to FDA-approved clinical trials.
• Reduced Regulatory Risks
  Comprehensive preparation minimizes delays, clinical holds, or FDA rejections.
• Efficient Resource Utilization
  Early FDA feedback helps refine strategy, streamline timelines, and optimize costs.
• Enhanced Market Reputation
  A well-prepared IND strengthens scientific credibility and positions the company for long-term success.

Who Is Responsible for the IND Application?

• Sponsors (Pharma, Biotech, or Academia) – Hold overall responsibility for initiating and managing the IND.
• Clinical Investigators – Conduct the trials and safeguard data integrity.
• Regulatory Affairs (RA) Teams – Manage submission strategy, FDA communication, and compliance.
• Quality Assurance (QA) Teams – Validate compliance, documentation, and manufacturing standards.
• Institutional Review Boards (IRBs) – Provide ethical oversight and protect trial participants.

Why Partner with BioBoston Consulting for IND Applications?

At BioBoston Consulting, we help clients navigate the complexity of IND preparation and FDA submission with confidence. Our services include:

• Expert IND Strategy Development – Aligning submissions with FDA requirements and expectations.
• Comprehensive Dossier Preparation – Compiling and reviewing preclinical, manufacturing, and clinical data.
• FDA Liaison & Submission Support – Handling pre-IND meetings, submission processes, and responses to FDA feedback.
• Lifecycle IND Management – Supporting amendments, safety reporting, compliance, and regulatory communications throughout the trial.

With our guidance, clients avoid common pitfalls and accelerate the pathway to clinical development.

Begin Your Clinical Journey with Confidence

The Investigational New Drug (IND) Application is the key to moving your drug candidate into clinical trials. Don’t let regulatory complexity slow down your progress.

📩 Contact BioBoston Consulting today to learn more about our customized IND Application consulting services. As your One Stop Solution for Life Sciences, we ensure your clinical development journey is faster, safer, and fully compliant.