Get in touch with Onix Today!
Contact us and use reference ONIX19.
Our expertise is what our clients value the most, during your COVID-19 submission please rely on us as your regulatory operations experts as we can guide you through the submission process.
If you would like to discuss your requirements, ONIX are offering a free 45 minute consultation in which we can answer any questions you may have. Leave us your details in the contact form, just quote code: ONIX19.
If you would like to get started, please leave your details and we will send you the ONIX online submission form. We will also provide you with a document plan to list the documents, so that we have a method to track, then you can send them to us via secure FTP.
We would then complete word formatting and PDF Publishing if necessary. We’ll then do the submission compilation, in the required format of eCTD. Once our internal QC is complete, we’ll provide it to you for review via an eCTD Webviewer or send it back to you via FTP. At this point you can request amendments and once you have provided your approval for it to be submitted, we will ensure it is technically valid and can then make the upload via the FDA Gateway. We will archive your submission and can then manage the lifecycle of your application.