The Situation

A small biotech firm was in the process of submitting its first product for registration to worldwide regulatory agencies with limited knowledge of the regulatory aspects of technology surrounding their application, quality system and preparedness for inspection.

The Solution

DQA provided insight into the current regulatory frameworks, conducted on-site inspection preparation meetings. Assisted with the completion of inspection questionnaires and completed internal audits of key systems that were in scope of the submission

Results

The company successfully navigated their first submission, and their product is now approved for use. The areas of the company that were prepared and received an audit were ready to answer the questions from the regulatory agencies which they had been trained for.

DQA Advantage

Success. As the principal consultant had been through many inspections, and, had dealt with the unexpected results of inspections such as regulatory actions, the company that contracted with DQA had knowledge of all scenarios that could be expected, and could answer questions eloquently with the right amount of detail.