Friday, January 15, 2010

The Benefits of QC - Clinical/Regulatory Submission

The benefits of quality control of clinical/regulatory submission data and documentation is obvious, speaks to ROI - return of investment and ensures fileabilty of the dossier.

The obvious benefits are, to mention a few:
  • fast track FDA review
  • fast track approvals
  • less Q&A, post-file
  • less Q&A with advisory committees
  • less Q&A with expert panels
  • less Q&A post-approval
  • clinical submission content is credible
  • cost effective
  • time effective
  • on time team review
  • timelines are keep, fast tracked
  • provides, well-controlled data and documents
  • ensures confidence in the accuracy of data and documents
  • ensures confidence in the accuracy of current and previously submitted clinical submissions and filings
  • provides user-friendly data and documents to the end user - FDA, Worldwide
  • coming in under budget.

QC is different than QA. Often pharma mistakes the two tasks, both are necessary, both are essential, both are important points to consider in the early planning stages of clinical/regulatory submissions.

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