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Cunesoft Regulatory Compliance - Online
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SaaS based Regulatory Compliance - provided by Cunesoft
SaaS based Regulatory Compliance - provided by Cunesoft

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When managing your #regulatory information feels like a goat rodeo.. we can help! Meet #Cunesoft at #DIA2018 Annual meeting, booth #2030. Learn all about newest, fastest and user-friendly #software #solutions for your regulatory operations! www.cunesoft.com
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Don’t hide yourself! Show your superpowers! Come to booth #2030 and grab this awesome postcard – tell the world that you are regulatory superhero! Boston, #DIA2018 Annual meeting - Cunesoft Booth #2030. We offer you the best solutions for your regulatory adventures! More info at www.cunesoft.com
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FDA proposes process modernization to support new drug development. These changes are intended to free up resources so that there would be more time spared to focus on drug development, particularly for unmet medical needs. The proposals include regulatory and review process changes, as well as organizational restructuring. To access full article, follow the page: https://blogs.fda.gov/fdavoice/index.php/2018/06/fda-proposes-process-modernization-to-support-new-drug-development/ If you or your colleagues need a regulatory compliance solutions – check out www.cunesoft.com ! #IDMP #eCTD #RIMS #SOP #RDMS #DataMining
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Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) is making changes with eCTD validation criteria, specifically current eCTD Document Matrix (Version 2.0) which forms part of the validation criteria for the eCTD and NeeS and which is one of file downloads for eCTD version 3.1. Read our newest blog post and learn more about details on Australia’s eCTD changes https://cunesoft.com/2018/06/14/australian-regional-specification-ectd-3-1/ . Cunesoft is ready for eCTD version 3.1. Are you? Write us and schedule a call: info@cunesoft.com
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Meet Cunesoft at DIA Annual Meeting 2018 in Boston! 25-27th June at Boston Convention & Exhibition Center, Booth #2030! Don’t miss a chance to speak with our regulatory experts and get to know the most modernized compliance software & solutions available. Write us and schedule your meeting – info@cunesoft.com
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The UK’s Business, Energy & Industrial Strategy Committee recently released a report, noting that regulatory divergence between EMA and UK could cause £45,000 extra costs for each newly released product, making the UK an unattractive market for new and innovative medicine. This and other EU regulatory news in RAPS regulatory roundup: https://www.raps.org/news-and-articles/news-articles/2018/5/eu-regulatory-roundup-uk-report-warns-of-divergen?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails&_zs=GWBtF1&_zl=59AT4
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Are you a clinical researcher? Do you plan to submit your IND? Do you know that you need to use the eCTD format now? Yes, since the 5th of May 2018 all INDs need to be submitted in eCTD format. Good news – Cunesoft can help you with that! We offer eCTD software: fast, reliable, user-friendly and with our outstanding support team - we guaranty your 1st submission will be compliant. Write to us! I bet we can find the best solution tailored for your research! https://cunesoft.com/en/products/ectd/ind
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The European Parliament adopted the General Data Protection Regulation (GDPR) in May 2016, and this year, it entered into force. The new regulations promise to have a far-reaching impact for businesses and organizations across the board, including pharma companies. GDPR will impact areas such as Health data, Clinical trials, Reaching compliance and others. Read full article here: https://themedicinemaker.com/issues/0418/gearing-up-for-gdpr/
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IND submissions in eCTD format is now mandatory and many organizations are still struggling with new regulations and high expectations. While Cunesoft is offering our sophisticated regulatory submission software cune-eCTD, DIA is offering a learning course: Regulatory Affairs: The IND, NDA and Post-Marketing. It is an opportunity to learn and understand FDA regulations and expectations for the content, submission and review of INDs/NDAs. Check the course here: http://ow.ly/t31230k7mCD and visit our page https://cunesoft.com/en/products/ectd/ind
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