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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Struggling with outdated dossiers and complex regulatory requirements?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.

Whitepaper: Computerised System Validation & Pharmacovigilance

Whitepaper: Computerised System Validation & Pharmacovigilance

Gain insights into optimised CSV solutions, and their role in effective risk management. Key Highlights: In-depth CSV risk management strategies Ensuring data integrity and reliability in PV systems Case study on validating a cloud-based safety database At Biomapas,...