eCTD NEWS
RECENT NEWS
EMA Clinical Trials Information System Webinar: Second Year of Transition , Online, 13:00 - 17.30 Amsterdam time (CET), from 04/07/2023 to 04/07/2023 (updated) Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission , Online,...
EMA Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages Template or form: QRD Appendix V - Adverse-drug-reaction reporting details(updated) eSubmissions (eCTD) Updated PLM Portal eAF Release notes now available...
JOINT WEBINAR: FRAMEWORK SOLUTIONS (ONIX)/IQVIA The implementation of eCTD 4.0 offers several benefits to organisations, improved efficiency and accuracy in regulatory submissions, enhanced collaboration with regulatory authorities, and the ability to use new technologies and...
EMA IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) Provisional mandate, objectives and rules of procedure for the Nitrosamines Safety Operational Experts Group (NS OEG) Medical...
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EMA Clinical Trials Information System Webinar: Second Year of Transition , Online, 13:00 - 17.30 Amsterdam time (CET), from 04/07/2023 to 04/07/2023 (updated) Clinical Trials Information System (CTIS) bitesize talk: IMPD-Q only submission , Online, 15:30 - 17:00 Amsterdam time...
EMA Regulatory and procedural guideline: Good practices for industry for the prevention of human medicinal product shortages Template or form: QRD Appendix V - Adverse-drug-reaction reporting details(updated) eSubmissions (eCTD) Updated PLM Portal eAF Release notes now available An updated version of the PLM...
JOINT WEBINAR: FRAMEWORK SOLUTIONS (ONIX)/IQVIA The implementation of eCTD 4.0 offers several benefits to organisations, improved efficiency and accuracy in regulatory submissions, enhanced collaboration with regulatory authorities, and the ability to use new technologies and data standards. Register to join...
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BLOGS
The use of electronic Common Technical Documents or eCTDs has revolutionised regulatory procedure. Providing a vital link between organisations within the pharmaceutical sector and regulatory health authorities like the FDA and EMA, eCTD submissions offer a convenient and efficient way...
The benefits of eCTD are many. As the mandatory format requirement for several regulatory health authorities – including those in Europe, the US, Canada, Switzerland, Australia, GCC, South Africa, Japan, Thailand and Jordan – eCTDs offer the efficiency, formatting and...
As this revision history proves, the FDA updates its specifications for eCTD validation criteria continually, a fact that makes it extremely difficult to keep up with the changes and so easy to miss an update. Whilst eCTD submission specialists like...
The FDA is just one health authority that has made the submission of ANDAs, NDAs, BLAs, DMFs and Commercial INDs in eCTD format mandatory. With paper and non-eCTD submissions no longer accepted across many application types, getting to grips with...
When preparing your eCTD submission, every little helps. An eCTD (electronic Common Technical Document) submission is after all an extremely complex process, with the tender of regulatory information such as applications, reports and supplements, and the associated documentation and cross-links...
eCTDs are no new thing. This would-be global standard was launched in 2003 within the regulatory health industry to ensure both technical and regulatory requirements were met with the effectiveness and efficiency that technology allowed. Since then, the use of...
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