One Stop Solution for Life Sciences
Breaking into human clinical trials is a pivotal milestone in drug development. The Investigational New Drug (IND) Application is the essential formal request sent to the U.S. Food and Drug Administration (FDA) to authorize investigational drug administration in humans. At BioBoston Consulting, we simplify this complex journey—positioning ourselves as your One Stop Solution for Life Sciences.
What Is an IND Application?
An IND Application is a critical regulatory submission to the FDA, requesting approval to conduct human clinical trials and ship investigational drugs across state lines.
The application must include three core components:
- Preclinical Data: Laboratory and animal study results that affirm the drug’s safety for initial human exposure.
- Manufacturing Information: Comprehensive details regarding composition, manufacturing processes, stability, and quality control of the drug.
- Clinical Protocols & Investigator Information: Study design, methodology, objectives, and credentials of clinical investigators overseeing the trial.
Once submitted, the FDA typically has 30 days to review the application. If no hold or objection is issued, the IND becomes effective—allowing clinical trials to begin.
Why Is the IND Application Important for Clients?
- Legal Authorization for Clinical Trials
Securing an IND is mandatory to lawfully initiate human testing and interstate drug shipments. - Safety and Scientific Integrity
The FDA rigorously assesses preclinical findings to confirm that human subjects are not exposed to undue risk. - Strategic Development Foundation
IND approval lays the groundwork for subsequent clinical trial phases and eventual marketing approval. - Enhanced Stakeholder Confidence
Approval signals regulatory soundness and ethical rigor, bolstering credibility with investors and partners.
How Is It Beneficial to Clients?
- Clear Development Roadmap
A structured pathway from preclinical evaluation through human trials. - Regulatory Risk Mitigation
Proactive planning reduces the chance of FDA-imposed clinical holds or delays. - Optimized Resource Allocation
Early feedback and refinement streamline development timelines and conserve resources. - Reputation for Quality and Compliance
A well-managed IND enhances scientific credibility, market readiness, and stakeholder trust.
Who Is Responsible for the IND Application?
- Sponsors: The individual or organization (e.g., pharma company, biotechs, academic institution) that initiates and oversees the clinical investigation.
- Clinical Investigators: Professionals responsible for executing the clinical trial and ensuring data integrity.
- Regulatory Affairs (RA) Teams: Experts who prepare, navigate, and manage the IND submission and communications with the FDA.
- Quality Assurance (QA): Teams that validate document compliance, manufacturing controls, and protocol quality.
- Institutional Review Boards (IRBs): Provide ethical oversight to ensure participant safety and informed consent adherence.
Why Partner with BioBoston Consulting?
As your One Stop Solution for Life Sciences, BioBoston Consulting offers:
- Expert guidance on IND requirements and FDA expectations
- Development of comprehensive, high-quality IND dossiers
- FDA liaison and submission support—including pre-IND strategy and follow-through
- Holistic lifecycle support through amendment submissions, trial compliance, and regulatory communications.
Ready to Begin Your Clinical Journey?
Don’t let regulatory hurdles slow your innovation down.
Contact BioBoston Consulting today to explore bespoke IND Application services designed to accelerate your drug development with confidence and precision.