eCTD NEWS
RECENT NEWS
EMA 04/08/2023 Newsletter: CTIS newsflash - 4 August 2023 eSubmissions (eCTD) 01-08-2023 Updated PLM Portal eAF Guide to Registration is now available Please find an updated version of the PLM Portal eAF Guide to Registration...
EMA 27/07/2023 PRIME: priority medicines(updated) 26/07/2023 Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS, Online, 15:30 - 17:00 Amsterdam time (CEST), from 30/08/2023 to 30/08/2023 19/07/2023 Big...
FDA 17/07/2023 Medical Device - Qualification of Medical Device Development Tools 19/07/2023 0356h Forms
EMA 13/07/2023 Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 (updated) 12/07/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what...
End of content
No more pages to load
EMA Newsletter: CTIS newsflash – 18 August 2023 Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS , Online, from 15/09/2023 to 15/09/2023
EMA 04/08/2023 Newsletter: CTIS newsflash - 4 August 2023 eSubmissions (eCTD) 01-08-2023 Updated PLM Portal eAF Guide to Registration is now available Please find an updated version of the PLM Portal eAF Guide to Registration here. MHRA Register medical devices...
EMA 27/07/2023 PRIME: priority medicines(updated) 26/07/2023 Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS, Online, 15:30 - 17:00 Amsterdam time (CEST), from 30/08/2023 to 30/08/2023 19/07/2023 Big data(updated) 19/07/2023 The use of...
End of content
No more pages to load
BLOGS
eCTD (electronic Common Technical Document) submission is an extremely complex process, which means it helps to be prepared. When submitting regulatory information such as applications, reports and supplements in this standard format, the documents and cross-links required have to be...
An electronic Common Technical Document, or eCTD as it is more commonly referred to, offers a standard format for submitting regulatory information to health authorities. As a result, it is an integral part of how organisations within the pharmaceutical sector...
As the standard format of submitting regulatory information to health authorities, an eCTD or electronic common technical document is essential for all organisations within the pharmaceutical industry. Used worldwide for the submission of applications, supplements and reports, an eCTD ensures all...
Creating documents for an eCTD application is time consuming and involves numerous authors, resulting in document formatting inconsistencies and a lengthy review and approval process. The ONIX eCTD Microsoft Word templates streamline the process by providing a standard structure. What...
To get your drug into clinical trials in the United States, you first need to obtain Investigational New Drug (IND) approval from the FDA (Food and Drug Administration). This may sound simple, but even getting to the stage of applying...
One of the eCTD publishing services we offer here at ONIX is PDF formatting. This is an essential part of eCTD submission. We must ensure we follow the industry guidance on PDF (portable document format specifications) to meet the maximum...
GET IN TOUCH WITH ONIX TODAY!
Contact us using the form below.
If you would prefer to call or email us: +44(0) 1753 257 904 or info@onixls.com
"*" indicates required fields
SUBSCRIBE TO OUR NEWSLETTER
Join our mailing list to receive the latest news and updates from our team:
