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PAI and BLA Submission Assistance

Quality Assurance
Inspection Readiness
Quality Systems
Ten expert consultants provided to re-submit failed BLA.
The Challenge

Our client, a large Biopharmaceutical company, submitted and subsequently failed a Biologics License Application (BLA) due to issues with their data integrity and quality systems. Additionally, the client needed to prepare for an upcoming Pre-Approval Inspection (PAI). Their Chief Quality Officer recognized the considerable challenges ahead and contacted Oxford Global Resources about our capabilities to support these initiatives. The Chief Quality Officer had worked with Oxford Global Resources in the past and was impressed with the quick turnaround, accessibility to a large number of quality candidates, and our willingness to listen and adjust the project plan to suit their needs.

The Solution

At the start of the initiative, the client was connected with three Oxford consultants to provide quality oversight to the client’s internal team and a third party vendor. The consultants were expert BLA Data Reviewers, QA Reviewers, and Technical Writers; most of whom had backgrounds in biologics or pharmaceuticals. They re-reviewed trial documents and quality system documents, as well as the overall processes and suggested improvements.

Four months later, an additional two consultants were added to the team to support the BLA re-submission. Additionally, in preparation for the client’s Pre-Approval Inspection (PAI), Oxford provided ten experts to assist with the growing backlog of deviations. These deviations needed to be completed within a twelve-week timeline.

Over the course of the initiative, Oxford provided pre-screening and in-depth oversight of our onsite and remote consultant teams. These quality measures limited interview times, strengthened the partnership between Oxford and the client and helped ensure maximum consultant team performance.

The Result

Although each consultant was working from different locations both onsite and remote, the client was able to successfully re-submit their BLA, which is currently in review. Oxford continues to partner with them to close out their deviations and ultimately achieve their long-term goal of launching their new product to market in a timely fashion.

When asked what they thought about Oxford’s services thus far, the client stated: “Oxford maintains open dialogue and good communication, and ensures the consultant staff are meeting or exceeding expectations.”