New Drug Application Support

Running clinical trials for new drugs, invitro diagnostics or even medical devices involves continuous site monitoring and FDA compliant practices.

Our regulatory experts have decades of experience working with FDA by writing submission documentation, communicating with regulators and completing complex drug development reports. These factors are all critical requirements to complete Investigational New Drug applications and Abbreviated New Drug Applications.

Our expertise lies in Drug Master File Review and Remediation, CMC Report Development to support clinical manufacture, as well as protocol review and remediation to ensure you have the scientific and technical basis for a successful clinical trial.

Compliance Team is ready to help you gain approval of your new drug.