Dossier Transformation for Market Expansion

Dossier-Transformation-for-Market-Expansion-_Case-study
Struggling with outdated dossiers and complex regulatory requirements? We partnered with a large pharma company to transform a fragmented legacy submission into a fully CTD-compliant dossier for successful market expansion in Europe.

In this case study, we break down how we:

 

  • Navigated legacy formats and rebuilt submissions to meet CTD standards
  • Handled multilingual data and inaccessible references efficiently
  • Built a scalable dossier structure that reduces future workload

Download the case study to learn about ensuring smooth regulatory review, minimal queries, and no delays to market entry.

Global Literature Review: Ensuring Safety through Robust Processes

Global Literature Review: Ensuring Safety through Robust Processes

In pharmacovigilance, timely identification of safety signals is essential to protecting patients – which is why our Global Literature Review (GLR) process provides a systematic and reliable way to capture, analyze, and document safety data from trusted scientific...

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