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