eCTD 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....
Industry View: Consequences of the New Variations Regulation for the ECTD
November 25 by Pharma IQElectronic submissions can substantially reduce submission time, allowing for a quicker release of products onto the market. However, the implementation and handling of eCTD can be problematic...
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...
Do Electronic Submissions Save Pharmaceutical Companies Time? 62% says Yes!
August 05 by Pharma IQ NewsWith eCTD submissions taking a firm hold in the US and Japan, they are now making their mark in Europe. Now that eCTD submissions are becoming the preferred format for regulatory submissions in Eu...
eCTD Continues Rise to Global Prominence
June 18 by Pharma IQThe ability to meet standards and regulatory approval is nowhere more important than in the pharmaceutical industry. All companies have responsibilities when it comes to submitting information to...
Getting eCTD Submissions Right
June 18 by Pharma IQWhile technology has undoubtedly had an impact on the techniques pharmaceutical firms use to develop new drugs, the digital revolution has also had a major effect on how they meet the number of re...
Are You Prepared for eCTD Submission?
March 28 by Andrea CharlesKlaus Menges, Division of Strategy and Planning, at the Federal Institute for Drugs and Medical Devices, BfArM, joins Pharma IQ, to discuss successful strategies for eCTD submission. To listen...