Need eSubmissions Fast? Meet ONIX

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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The ONIX Process Workflow

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…