eCTD Industry Update (8 Feb 2022)
EMA Referrals document: Nitrosamines EMEA-H-A5(3)-1490 – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated) Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated) Regulatory and […]
The Template Toolbar
Tired of corrupt documents? Want a bit more automation in your authoring? Maybe it’s time to use a template toolbar created by experts! The team of consultants at ONIX have created a solution that can help with: Pre-defined Heading Styles Embedding #eCTD Numbering Pasting Unformatted Text Copying & Reformatting Tables Predefined and User Custom Document […]
Updated FAQ!
All your eCTD and Regulatory questions are answered! Check it out: www.onixls.com/faq/ Did we leave any questions unanswered?
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’s electronic portals. Once done, you will […]
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, […]
