Changing Regulatory Requirements Present Complex Challenges

The evolving regulatory environment is causing transformation of Trial Master File (TMF) Management and Oversight. Regulatory authorities are now more focused on active TMF Management. This has resulted in an increase in major and critical inspection findings with 50% of critical findings related to record keeping and essential documents.

Incomplete and/or errors in the TMF not only leads to regulatory incompliance, but may also lead to delayed regulatory submissions, increased audit activity, delays in getting medicines to patients and significant financial losses.

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