Challenge2 | Bracane Company, Inc
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CASE STUDIES

Challenge 02

Biotech hires BCI for compliance audit prep for Oncology product pre – BLA submission for phase I/IIB study

Solution

  • Clinical Operations and Site Audits

  • Gap Analysis

  • Mock audits/consultation post FDA inspection

Results

  • Team identified trained – Day 3

  • Internal audit/gap analysis

  • Site audits

  • Supported company through regulatory inspection

  • Support provided through regulatory response

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