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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...
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...
All your eCTD and Regulatory questions are answered! Check it out: www.onixls.com/faq/ Did we leave any questions unanswered?
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...
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eSubmissions (eCTD) The 1st DADI newsletter has been published on the EMA website The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of...
EMA News and press releases: Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
EMA News and press releases: EMA launches pilot project on analysis of raw data from clinical trials Other: Information about the raw data proof-of-concept pilot for industry eSubmissions (eCTD) DADI eAF Portal Guide to Registration now available The Digital Application Dataset Integration...
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