eCTD NEWS
RECENT NEWS
CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP...
EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to...
EMA EMA Account Management training webinar Quarterly system demo - Q3 2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
EMA IRIS guide for applicants - How to create and submit scientific applications for industry and individual applicants (updated) CMDh Update: Step 2 - No nitrosamine detected response template Update: EMA/CMDh explanatory notes on Variation Application Form -...
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CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP / Update assessment report Update - CMDh Best...
EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to 22/09/2022 (updated) Clinical Trials Information System...
EMA EMA Account Management training webinar Quarterly system demo - Q3 2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
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BLOGS
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...
The eCTD validation criteria are a set of standards that must be met in order for an eCTD submission to be considered valid. These criteria are designed to ensure that the submission is complete and accurate and that all required...
In previous posts, we have discussed what eCTD is and what an eCTD submission is. This post will look at electronic submission gateways and how they can be used to submit regulatory documents. Electronic submission gateways have been implemented to...
The eCTD is comprised of 5 modules, each of which has its own requirements in terms of documents and content. The benefits of eCTD include: eCTD has become a mandatory format requirement for many regulatory health authorities; Europe, the US,...
All life science companies require approval from Regulatory Health Authorities to place their human, medical device, or veterinary medicinal products on the market. For approval to be granted, the drug application data needs to be submitted in an electronic format,...
All life science companies require approval from Regulatory Health Authorities to place their human, medical device or veterinary medicinal products on the market. Electronic common technical document (eCTD) is a mandatory format for submissions to Regulatory Health Authorities, which is...
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