Launching a new drug in the United States requires rigorous compliance with FDA regulations, starting with the Investigational New Drug (IND) application. An IND is mandatory before beginning any clinical trials involving human subjects. It ensures that the investigational product is safe for testing and that the study design meets ethical and scientific standards.

The IND submission allows sponsors to legally ship an investigational drug across state lines and administer it to humans for research purposes. This process is critical for both pharmaceutical innovators and biotechnology companies looking to bring novel therapies to market.

Key components of a successful IND include:

• Preclinical Data – Animal pharmacology and toxicology studies to demonstrate safety.
• Chemistry, Manufacturing, and Controls (CMC) – Information about drug composition, stability, and manufacturing processes.
• Clinical Protocols – Study design, dosing, patient population, and monitoring procedures.
• Investigator Information – Qualifications of clinical investigators and participating institutions.

The FDA reviews IND submissions to ensure patient safety and compliance with Good Clinical Practice (GCP). Sponsors must also maintain ongoing communication with the FDA throughout the clinical trial process, including annual reports, safety updates, and protocol amendments.

At XPRO America, we provide end-to-end Clinical Trial IND Support Services to streamline this complex process:

• IND Application Preparation – Compiling CMC, preclinical, and clinical data in the required format.
• Clinical Protocol Development – Designing scientifically sound and FDA-compliant study protocols.
• Regulatory Liaison – Communicating with the FDA during the review process and throughout the trial.
• Compliance Monitoring – Ensuring adherence to GCP and FDA reporting requirements.
• Ongoing IND Maintenance – Submitting amendments, annual reports, and safety updates.

With our expertise, sponsors can reduce delays, avoid regulatory pitfalls, and ensure their investigational drugs move efficiently through the clinical development pipeline.

XPRO America offers FDA IND support for clinical trials, including application prep, protocol design, and regulatory communication for safe, compliant studies.