Regulatory File Audit and FDA Submission Support

Study closure and regulatory submission can be a challenging time. BMA will be there to support your team during this critical period. Following FDA regulations, as well as your internal SOPs and guidelines, BMA will review regulatory documents, investigator, country and central files, providing a full tracking and reconciliation of all documentation. We will perform due diligence with sites and liaise with central and local IRBs in order to clarify discrepant information and collect missing documents.

BMA will also provide interim and final reconciliation of FDA Form 1572s, comparing them to site utilized local laboratories, as well as confirming that all forms have been appropriately submitted to your regulatory department. As needed for submission, BMA will also collect and reconcile interim Financial Disclosure Forms to ensure proper financial reporting and disclosure for all Investigators listed on the 1572.

If requested, our specialized staff can visit Investigator sites to perform an on-site review of the regulatory documentation to ensure compliance, completeness and accuracy. Any missing documentation will be highlighted to site personnel and Sponsor via full verbal and written report.

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