Investigational New Drug Applications (IND)

Regulatory Affairs Services – Overview

To conduct clinical trials in the United States with an investigational drug not yet approved for its intended use, sponsors must submit an Investigational New Drug Application (IND) to the US FDA and obtain acceptance before the drug is transported or distributed for clinical use.

Failure to provide sufficient information regarding product quality, safety, and scientific evidence of efficacy can result in a Clinical Hold (full or partial), preventing progression until the FDA’s concerns are addressed.

Key challenges in the IND filing and approval process include:

• Identification of the Regulatory requirements for the intended IND submission (Phase I, II, III).
• Ensuring GMP/GLP compliance throughout the IND approval process.
• Addressing product-specific scientific issues, including New Chemical Entities, biologics, or radioactive-labeled drugs.
• Managing clinical hold issues and developing mitigation strategies.
• Coordinating IND submission with clinical trial logistics, including site readiness, clinical material manufacturing/testing, and cGMP compliance at CMO sites.
• Managing ongoing CMC and protocol changes while ensuring compliance with federal regulations for an active IND (including CMC amendments, protocol amendments, safety reporting, and annual reporting).

X Pharma Plus provides end-to-end Regulatory support for the IND approval process, from pre-IND meetings to submission, FDA interactions, and ongoing compliance management, ensuring a smooth and efficient pathway to IND effectiveness.