Investigational Filings and Maintenance

Home Services Investigational Filings and Maintenance

Any drug that does not currently have FDA approval for marketing requires an Investigational New Drug Application (IND) before it can be administered as a part of a research study. In some cases, an FDA-approved drug must also be conducted under an IND. Years of research in multiple specialties are required to produce the totality of evidence necessary to support advancing a new drug into human trials. BLA Regulatory works with our clients, the sponsors, to present the best case to the regulators by compiling a robust data set describing how the drug is made and determined to be pure and potent, the results of testing the effects of the drug in animals, and the plans for exploring exposure in humans as safely as possible. We also review the data required to support filing an IND in the United States. Our IND services include:

  • Facilitation of Pre-IND Meeting
  • Review of Administrative, Animal pharmacology and toxicology studies, Manufacturing Information, Clinical Protocols, and Investigator Information
  • Compilation of Dossier according to Agency Requirements
  • Strategic Response to Clinical Hold and Health Authority Questions
  • IND Maintenance: Amendments, Annual Reports, Safety Reporting
  • Withdrawal, Termination, and Inactivation