electronic submissions
Best Practice Tips for Successful eCTD Submissions
January 14 by Helen WinsorYann Kervevan, EMEA Regulatory Affairs Operations Manager, Alexion Pharmaceuticals, joins Helen Winsor from Pharma IQ, to dicsuss the challenges in eCTD implementation and electronic submissions....
eCTD Transforms Pharma
November 08 by Pharma IQEnusring eCTD readiness is now a major concern for all pharmaceutical companies seeking to gain first time approval, as more regulators move towards the eCTD (electronic commo...
Embracing eCTDs and Electronic Submissions
October 20 by Pharma IQIn the past few years, the very way pharmaceutical organisations submit their applications for drug approval has become an essential issue to consider. While paper-based submissions have been a m...
Effective Information Management to Aid Regulatory Submissions: What Do You Do to Make it Work in Practice?
September 13 by Helen WinsorPharmaceutical companies are placing even more importance on the pharma regulatory aspects of data and information management and how efficiently information is translated to drug...
eCTD Rises in Popularity Across Europe
August 09 by Pharma IQAs a growing number of industry authorities confirm that they only intend to accept documents for approval in electronic form, the concept of the electronic common technical document (eCTD) has risen...