Quality Review of Submission Documents

Pre-submission Drug Application Review

Once an application is received by the FDA, they first verify that the necessary documents are present. If anything is missing, they will either refuse to file, or not review the application until the missing documents are submitted. We perform a pre-submission review of pharmaceutical application documents, looking for completeness of the application, consistency, and accuracy of the application.

Once the application is accepted, the reviewer will look for consistency and completeness of the supporting documents. If there is inconsistency, or missing data, the review process can be delayed while the issues are resolved. Our goal is to help you achieve the fastest review possible by assuring that the documents submitted are complete, consistent, and that the correct supporting documents are in place.

Regulatory Issues

Your firm may be required to correspond with the agency to resolve regulatory issues. These may come about from an FDA inspection, an event with a distributed product, a complaint that is being investigated, or some other catalyst. We offer assistance in preparing and editing a post-inspection response to the form 483, and/or subsequent follow-up documents to help you address possible regulatory concerns. We will help you assess what actions will be necessary to either address FDA concerns, or if a regulatory action is underway, help you bring your firm back to an acceptable status with the FDA. We will arrange a meeting with FDA if required.