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

Result

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