What Is an Investigational New Drug (IND) Application?

An Investigational New Drug (IND) application is a formal request submitted to the U.S. Food and Drug Administration (FDA) seeking permission to administer an investigational drug or biologic to humans. It is a mandatory regulatory milestone before initiating clinical trials or shipping the investigational product across state lines. The application includes comprehensive preclinical data (pharmacology, toxicology), Chemistry, Manufacturing and Controls (CMC) information, and the proposed clinical protocols to ensure patient safety and trial integrity

Why Is IND Application Support Important?

• Regulatory Compliance & Safety Assurance: IND submission assures the drug’s safety profile and trial design meet FDA criteria, reducing risk of clinical hold or rejection
• Strategic Efficiency: Early pre‑IND meeting support and regulatory strategy help navigate regulatory expectations, avoid costly mistakes, and streamline timelines
• Credibility Boost: A professionally structured IND package enhances sponsor credibility with regulators, investors, and study sites

How Clients Benefit from BioBoston Consulting’s IND Services

• Customized Strategy & Roadmap: We craft an IND blueprint relevant to your drug’s modality, indication, and development goals—from preclinical through clinical launch
• End-to-end IND Preparation: Our experts compile the Investigator’s Brochure, CMC data, preclinical study reports, clinical protocols, and administrative documentation into a cohesive package
• PreIND and Agency Engagement: We support preparation for FDA pre-IND or Type B meetings, facilitating constructive dialogue and reducing uncertainty
• Response & Submission Management: BioBoston manages submission logistics, responds promptly to FDA inquiries, and helps minimize review delays
• Seamless Integration with Later Phases: We align your IND strategy with later regulatory activities (e.g., NDA/BLA), enabling consistent progress through clinical phases

Who Is Responsible for the IND Application?

A dedicated and multidisciplinary team at BioBoston Consulting manages the IND process:

• Regulatory Affairs Specialists: Lead regulatory strategy, classification, dossier preparation, and FDA interaction.
• Clinical Research Leads: Design and write clinical protocols, monitor safety and trial integrity.
• Quality Assurance & CMC Professionals: Ensure compliance with cGMP, data integrity, manufacturing controls, and Investigator’s Brochure accuracy.
• Project Managers: Oversee timelines, coordinate across functional teams, manage administrative and submission milestones

BioBoston Consulting offers expert Investigational New Drug (IND) Application services that take you from preclinical planning through FDA clearance. As a One Stop Solution for Life Sciences, our team delivers strategic guidance, robust IND packages, regulatory engagement support, and seamless coordination toward successful clinical trial initiation.

Ready to Move Your Drug into Clinical Trials with Confidence?

Partner with BioBoston Consulting—your One Stop Solution for Life Sciences—to navigate the IND application process with precision and speed. Let our team guide your investigational drug from discovery to IND clearance and beyond.

Contact us today to schedule a consultation and explore how our IND Application service can accelerate your clinical development journey.