eCTD NEWS
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Top 7 Questions to Ask Yourself Before Submitting That eCTD Application Working in an eCTD consultancy is probably the best place to see a wide variety of quick mistakes and rather large faux pas from...
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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DADI Human Variations eAF User Acceptance Testing (UAT) – Call for Volunteers In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite applicants to participate in the UAT of...
EMA: Regulatory and procedural guideline: Procedural guidance for variant strain(s) update to vaccines for protection against human coronavirus (updated) Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated): Regulatory and procedural guideline: European Medicines Agency pre-authorisation...
ICH: ICH electronic Common Technical Document – eCTD v4.0 CMDh: National recommendations for request to act as RMS (June 2022) MHRA: Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending – 24 June 2022 – Guidance...
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