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    • eCTD Submission Management Services
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  • eCTD NEWS
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eCTD NEWS

RECENT NEWS

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eCTD Industry Update (2nd May 2023)

EMA Template or form: CHMP protocol assistance scientific advice briefing document template (updated) Newsletter: News bulletin for small and medium-sized enterprises - Issue 58 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for...
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eCTD Industry Update (25th April 2023)

EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated...
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eCTD Industry Update (18th April 2023)

EMA Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated) Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical Clinical Trials Information System...
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eCTD Industry Update (11th April 2023)

EMA EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions News and press releases: New features further strengthen Priority Medicines scheme...
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eCTD Industry Update (9th May 2023)

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 devices (updated) Contact us to discuss...
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eCTD Industry Update (2nd May 2023)

EMA Template or form: CHMP protocol assistance scientific advice briefing document template (updated) Newsletter: News bulletin for small and medium-sized enterprises - Issue 58 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure:...
Read More
etch weekly update image

eCTD Industry Update (25th April 2023)

EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated PLM Portal eAF timeline now...
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BLOGS

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What is eCTD metadata?

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...
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Meeting table

How to get ready for eCTD submission

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...
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What is an eCTD viewer

What is an eCTD viewer?

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...
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streamline your esubmission with ONIX word template

How to streamline your eSubmission with ONIX predefined eCTD Word templates

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...
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what is needed for an investigational new drug application IND

What is needed for an Investigational New Drug Application (IND)?

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...
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portable document format specifications ectd submissions

What are the portable document format specifications for eCTD submissions?

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...
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