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 quality that should always come as standard when bringing a human, medical device or veterinary medicinal product to market.
Achieving benefits such as faster review and time to market, lower cost of production and storage, and a higher rate of work efficiency doesn’t come without its challenges, however. Whilst the review, handling and archiving of paper submissions was cumbersome, time-consuming and costly, eCTD submission can be just as complex without the right support.
Your electronic submission has to be in line with specific validation criteria as well as local and global requirements. Thankfully, there is a wide range of eCTD and electronic publishing services that you can access to ensure eCTD submission success every time.
Here we take a closer look at the eCTD and electronic publishing services available right here at ONIX.
Submission management
We can handle the management of your eCTD submission from start to finish. With extensive experience submitting eCTDs to EMA, MHRA, FDA, Health Canada, Swissmedic, Australia, ASEAN GCC, SAHPRA/MCCZA, EAEU and other global regulatory health authorities, we have the knowledge, expertise and understanding you need to deliver compliant, high-quality submissions.
We make the entire process as simple as possible for our clients by providing support with eCTD submission strategy, project management, eCTD compilation, MS Word formatting, PDF publishing, QC review, technical validation, gateway submission, continued eCTD lifecycle, and submission Webviewer hosting.
Regulatory advice
Keeping up to date with the latest regulations is the key to successful eCTD submission. Such changes can not only impact new eCTD submissions but affect ongoing lifecycle maintenance. Our advisory services bridge the gap between organisation and authority to ensure the regulatory environment can be navigated with ease in the short and long term.
Our experts deliver best practice guidance to guarantee overall efficiency and compliance in relation to the current eCTD requirements of regulatory authorities.
Our regulatory advisory offering goes beyond eCTD submission management to ensure a consultancy service you can trust. Our network of experienced consultants provides support and advice with clinical development strategy, data management and biostatistics, clinical trials, scientific advice, medical writing and strategy, regulatory affairs, pharmacovigilance, US regulatory agent, and SPL.
eCTD formatting
The use of PDFs and MS Word documents is essential for compliant eCTD formatting. Some aspects of your submission can only be provided in PDF form for instance as this excerpt on Case Report Forms (CRFs) from the FDA’s eCTDs Technical Conformance Guide explains:
“An individual subject’s complete CRF should be provided as a single PDF file. If a paper CRF was used in the clinical trial, the electronic CRF should be a scanned image of the paper CRF including all original entries with all modifications, addenda, corrections, comments, annotations, and any extemporaneous additions. If electronic data capture was used in the clinical trial, a PDF-generated form or other PDF representation of the information (e.g., subject profile) should be submitted.”
Our eCTD MS Word and PDF formatting services use best practice to publish and format your files accordingly. The correct format will help you avoid technical rejection, and ensure the latest standards and regional requirements are adhered to.
eCTD template automation
Our template automation option aims to simplify the eCTD process further. We give you access to an eCTD template suite to enable you to build and format compliant submission documents. With our predefined templates, you can remove the uncertainty that often accompanies eCTD submission and concentrate on developing the quality content within.
For further information on any of the eCTD and electronic publishing services mentioned above or to find out more about how ONIX can assist you, please get in touch with our team.
