Ensuring strict regulatory compliance for a leading pharma company
Success Stories | Health

Ensuring strict regulatory compliance for a leading pharma company

Business Issue

To meet the European Medicines Agency’s (EMA) Article 57 compliance requirements, the Regulatory Operations Group within a major pharma company reached out to Escalent for Marketing Authorization submission support.

What We Did

To deliver against our client’s need, we:

  • Identified and extracted medicinal product data from references, including product characteristics and licensing details
  • Performed quality control on Marketing Authorization submission data to ensure compliance with EMA standards
  • Updated medicinal product data and performed MedDRA3 Coding when required by leveraging SmPC1 and PEARL2 datasets
  • Led strategic meetings with the Regulatory Operations Group to review key developments
  • Conducted root-cause analysis for issue resolution


Our work with the Regulatory Operations Group resulted in:

  • An increased pace of Article 57 submissions by up to 6%
  • A reduction in error Article 57 submissions by upwards of 10%
  • Enabled accountability through detailed RCA reporting
  • Valuable time back for leadership to focus elsewhere

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