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De-merged entity ropes Indegene to check regulatory inspection readiness

De-merged entity ropes Indegene to check regulatory inspection readiness

De-merged entity ropes Indegene to check regulatory inspection readiness

Indegene
Pages 2 Pages

Indegene assisted a de-merged biosimilars entity of a global pharmaceutical company in assessing regulatory inspection readiness after separating its business, identifying 20+ critical findings across broad categories. Transition challenges included instability, quality issues, and deadline adherence by new vendors, prompting a second audit of end-to-end vendor and partner functions. Indegene's advanced software expedited Root Cause Analysis (RCA) and CAPA assessments under 3 months, automating audit workflows, standardizing compliance checks, and centralizing findings. This ensured robust readiness, mitigated risks, and restored operational stability swiftly.

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