All your eCTD and Regulatory questions answered! Check it out: www.onixls.com/faq/
Did we leave any questions unanswered?
All your eCTD and Regulatory questions answered! Check it out: www.onixls.com/faq/
Did we leave any questions unanswered?
Do you need eCTD submissions compiled with a quick turnaround? Send us your documents in an email or by secure File Transfer Protocol. We will compile the submission in the relevant format, provide it back to you for review, and once you’re happy we will submit using the agency electronic portals. Once done, you will receive the agency’s proof of delivery receipt, job done!
We are eSubmissions made easy!
Do you need to switch your products to eCTD? Need documents PDF published for submission readiness? Need to make an MAH transfer? Concerned about Brexit? Our team of highly skilled consultants are also offering a variety of other regulatory services; get in contact for a free consultation using code Onix-tube.
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Working in an eCTD consultancy is probably the best place to see a wide variety of quick mistakes and rather large faux pas from many different sources. Here is what we think are the top questions you need to be asking yourself before sending in that eCTD application. I am going to list these questions in the order that they may be problematic to you once submitting.
1. Have you contacted the relevant agency?
You could have the most perfect dossier prepared and ready for review but if the agency is not expecting it, what was the point of all your hard work? If you have to wait for the next window to submit then that could mean a revenue loss of millions, probably not the kind of loss your company desires. You will also want to register for their portal or gateway in order to transmit the submission to them in the easiest and quickest method possible, portal transmission can be done in minutes where as physical dispatch can take days, days that are better spent on improving the quality of your dossier. Once in contact with the agency and you have an agency expected date, is it feasible to meet this? Below are some additional questions to ask.
2. Is your submission technically validated?
So you have agreement with the agency, you have the date on which the agency is expecting your submission. But an eCTD submission package needs to pass technical validation before the agency will even accept it into their system, if this cannot be passed, review will not even begin. So it is imperative that all the eCTD technical requirements have been adhered to, this responsibility falling to your submission publisher, manager or consultant. This should be done periodically throughout the submission compilation process in order to avoid a massive amount of document/submission fixing in the last hour.
3. Do you have the latest fillable forms?
Have you sourced the latest and correct versions of the electronic administrative forms? This is no longer the case for EMA cover letters but there are still a number of forms that need be sourced and filled out electronically and not physically signed and scanned. If these are not filled in correctly they will be flagged as errors during the validation and rejected from the agency. To ensure you are using the latest forms please seek the latest agency guidance. For the EMA, the eAF can be found here. For the FDA, forms can be found here.
4. Are you following the PDF specifications?
Are the documents that are you are authoring in alignment with the PDF specifications? Not only should each leaf/document have a specific eCTD title applied and be placed into a specific location within the eCTD structure but each of these leaves should adhere to a set of prerequisites that can change slightly per agency. The PDF must be of a certain version, have fast web view applied and even the links and bookmarks have their own properties that need to be applied. Luckily the team at ONIX has used their expertise to create a Word template plug-in that can take care of all of these prerequisites, but in the absence of a template please be sure to source the latest PDF specifications. PDF specifications can be found in section 7 of the ICH eCTD Specification guideline.
5. Have hyperlinks and bookmarks been made to the correct destinations?
Hyperlinking is probably the most time exhaustive task available to a publisher but this time is far increased if the hyperlinking has items that need querying. The citing of referenced content can largely be correct, but even with a few issues a lot of time can be spent on resolution. This is because if the publisher cannot find the destination document/page there is no way of knowing if the content is missing or whether just one of the numbers in the citation is a typo meaning that the publisher has no choice but to query this with the author, usually meaning a multiple email exchange, sometimes taking days to find the resolution. One of the easiest but probably most important rules of citing and hyperlinking is to remember that a link can only be made to one document. For example, if a citation is made referencing the 3.2.S substance section, a link will not be able to be made as there are many documents within the substance section. Again, use of a template can automate the referencing and internal linking of a document while the external linking would be taken care of by your submission publishers/managers/consultants. Get in touch if you would like to hear how we can tailor a template solution for you.
6. Is your metadata correct?
It’s annoying, the amount of questions the submission publisher/manager asks about the detail of the submission? Why do they need to know? Why can’t they just publish the documents? Well the reason lies in the previously mentioned technical validation. If any part of the application metadata (submission number, applicant name and indication etc) or the sequence metadata (sequence number, submission type and description etc) are not present, then these will be flagged as validation issues by the validation tool and thus not be accepted by the agency.
7. Are you using Lifecycle operators correctly?
The operators in question are “new”, “replace” and “delete”. If these are not applied correctly it can be very misleading for a reviewer. For example if you are not “replacing” the previous version of the label with the latest up-to-date version, but instead add it as “new” then all previously submitted labels will technically still be the live and current versions. This is probably not the impression you are trying to give to the reviewer.
If you can answer all these questions with a confident and positive affirmation then you are most likely ready for dispatch. If you need any support or assistance with any of the steps listed above then get in touch with the team of experts at ONIX.
This is what we do and how we do it!
The first step is to send us your documents via secure FTP (or by email).
We would then complete word formatting and PDF publishing if necessary.
These tasks can be done for submission but we also offer these as stand alone services.
We’ll do the publishing, whether the required format is eCTD, NeeS, flat structure etc.
We’ll provide it to you for review via a viewer or send it back to you.
Once you’re happy for it to be submitted we can make the upload via electronic portal.
We can then manage the lifecycle of your product’s application for as long as you deem necessary.
eSubmissions made easy…
Know a more prevalent text editing software than Microsoft Word? Of course you don’t and that’s largely due to the fact that the word processing tool has been in our homes and businesses since the 80’s. For some of us that is around the same time our personal computing love/hate relationship began. It was first released in 1983 on Windows and has since reached a staggering 1.2 billion users. So chances are, if you work in any type of professional or corporate environment you will definitely be using this tool in some way, shape or form. The question is, are you using it in the most time effective manner? I mean after all, we would all like to work smarter, not harder.
So let’s look at some solutions that could very potentially help you to become a member of that work smarter movement. Not to say you are not already a Word wiz kid and maybe you’ve mastered a few commands and shortcuts. You know how to hit that Ctrl+Z button when you need to back up quickly and you may even know to hit Shift+F5 as you open a document to be taken to the last revision made before the document was closed. (I didn’t, I certainly did not know that last one before writing this article). However, you wouldn’t call yourself an expert and there is always room for improvement right?
That being said, have you heard of Writing Assistant? An artificial intelligence powered text checker that flags errors in your grammar and can be added as a plugin to Word, similar to Grammarly. Or maybe MyScript Math? A math equation editor that sits within Word. One of my favorites for convenience is the Wikipedia Word add-in, allowing the user to search and define subject matter within Word, reducing those switches between document and browser.
There are a few more Word plugin tools out there, but chances are if you’re reading this article then your industry might be a bit more niche and benefit from something a bit more fit for purpose. The previously mentioned solutions are great but they are main stream and you may very well know of them already. If you author or contribute anything to eCTD or the Life Science or pharmaceutical sectors then I may have the most tailored solution available.
ONIX Life Sciences Ltd has a team of skilled eCTD submission consultants with around 75 years of experience between us and we have used their experience to create an amazing template toolbar that can provide document consistency across all disciplines and contribute to writing documentation for submissions. The features include:
• Apply Pre-defined Heading Styles
• Embed eCTD Numbering
• Paste Unformatted Text
• Copy & Reformat Tables
• Predefined and User Custom Document Properties
• Landscape Pages with Correct Header/Footer Orientation
• Apply Internal & External Cross Referencing
• Blue Text for TOCs and Hypertext Links
• Easy-to-find graphic buttons
• Real Time Formatting Support from ONIX Consultants
Let me describe the magic in this scenario, the client was authoring components in eCTD 3.2.S & 3.2.P, but did not know the CTD prefix for each component, had no header or footer details, tables and figures were not cross referenced, table text was inconsistent all while landscape pages had incorrectly positioned headers. Sounds like a mess right? Not for the ONIX template toolbar, as once applied to the document it could consistently amend CTD numbering, headers and footers (including landscape pages) and text (including tables) throughout and also insert cross referenced tables and figures. All of this was fixed with the application of just one add-in, the ONIX Template Toolbar. Impressive right? And those are just a few of the functions!
Do you have any issues with Word that you are yet to find a solution for? Get in touch as we could help with that or get in touch if you would simply like to hear more! Our consultancy specialises in document formatting/processing and eCTD structure, publishing and management of documents and modules for electronic submissions but the team have found these skills transferrable for documents across many disciplines and industries. Let us know if we could help you as the team loves a challenge.
eSubmissions Made Easy…
Onix would like to welcome Justin Bailey to the team.
Justin has worked within the industry for over 11 years. He has a background in Submission Management, working for pharmaceutical companies and a Regulatory Operations software vendor.
Justin provides ONIX clients with consultancy advice and project management on global eCTD regulatory operation requirements. Justin is experienced in all aspects of e-submission publishing and oversees the management of eCTD submissions to health authorities and life-cycle management.
As a returning employee, he possesses a company familiarity not obtainable from any other new starter while also bringing a breadth of new experiences on board.
In between employment at ONIX he has taken on roles in Global Submission Management and Global Sales Consultantin the Pharmaceutical industry.
Justin has given talks at TOPRA, Informa and other Regulatory Operations conferences.