EXTEDO TO INCORPORATE FDA VALIDATION RULES IN EURS IS YOURS SOLUTION
Upcoming release to incorporate validation rules for US eCTD submissions
February 10, 2009, West Chester, PA. EXTEDO announced today that their upcoming release of EURS is Yours version 2.8 has been extended to incorporate FDA requirements. The addition of these rules will allow sponsors to validate an electronic dossier submission in accordance with the published FDA “eCTD Validation Criteria”.
EURS is Yours is designed for the validation, review, and application lifecycle management requirements of the EMEA and 37 EU national competent authorities (NCAs). While EURS is Yours continues to be the leading validation and review tool for most national authorities in the EU, the addition of the FDA validation criteria will allow sponsors to have a single solution that incorporates the recently published validation criteria of both the EU and US eCTD. In addition, EURS is Yours provides a true multi-user collaborative environment for viewing and annotating dossiers in both pre and post submission phases.
“EXTEDO closely monitors all new or changing guidances and specifications from the ICH, FDA, EU/EMEA, Health Canada and Japan” said Harv Martens, Extedo, Inc. Vice President of Operations for North America and Japan. “Our involvement in the EMEA led EURS Implementation Group and the IRISS Forum ensures that EURS is Yours meets the current requirements in relevant regions.“
EXTEDO plans to release version 2.8 of EURS is Yours in Q2 2009.
About EURS is Yours
EURS is Yours is a multifunctional software solution that serves as an overall eCTD validation and retrieval system. It reports whether a submitted eCTD-based application conforms with the official interpretation of the eCTD format. Furthermore it provides access to submissions allowing the user to search, view or print any required regulatory document.
About EXTEDO
EXTEDO is a leader in e-Submission solutions for highly regulated industries. With more than 600 customers and over a decade of experience, EXTEDO’s customers have been able to implement a proactive regulatory process that is fast and accurate.
EXTEDO solutions for life sciences are designed to achieve compliance with ICH and regulatory agency requirements for marketing authorizations and pharmacovigilance. EXTEDO enables organizations to bring new drugs to market faster with better quality submissions while proactively managing regulated content, reducing costs, and improving regulatory compliance. For more information visit www.extedo.com.
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Media contact:
Michael Kane
(978) 257-2179