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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...
Save More Time Using WORD in 2020 Know a more prevalent text editing software than Microsoft Word? Of course, you don’t, and that’s largely because the word processing tool has been in our homes and...
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...
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eSubmissions (eCTD) DADI Project Update Human variations forms updated timeline & revised go-live scope Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to...
EMA Webinar on submissions of parallel distribution notifications for centrally authorised products (CAPs) FDA Addition of the new validation error code 1738. Update to the 4.4 problems for error code 1735. Update the description and effective date for error code...
IRISS IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated) EMA Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen...
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