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Author name: Alp Tetikel

5 ways to automate your submission content preparation in Veeva with DocShifter - Accelerate your regulatory submissions and reduce time to market

5 ways to automate your submission content preparation in Veeva with DocShifter

Leave a Comment / Blog, Life Sciences /

1. Achieve document compliance earlier in your submission process when using DocShifter with Veeva (or any other repository) A typical drug development process takes from 5 and 15 years, and documentation is created every step of the way. Marketing Authorisation submissions are compiled at the end of this timeframe. Documents are typically only checked for […]

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How to automate SharePoint document preparation & report generation

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Are you using Microsoft SharePoint to store and manage your submission content? ​​The automation of regulatory content does not need to stop there. ​​Combined with the power of DocShifter, we can take automation to the next level. So you can focus on the content. ​​How will this powerful combination help you save time with the

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How to save time by fully automating your report level publishing and report generation needs webinar header

How to simultaneously render compliant PDFs for your global submissions (including a 15 minute practical demo)

Leave a Comment / Past Webinars, Automated Report Level Publishing Resource 1 /

Are you struggling to produce PDFs that meet the requirements of different regulatory agencies around the world? Do you find yourself spending hours, or even days, manually editing PDFs to meet the FDA, EMA, PMDA, etc. requirements? Today, this process does not have to be this complex and difficult. Join us in this webinar +

How to simultaneously render compliant PDFs for your global submissions (including a 15 minute practical demo) Read More »

How to save time by fully automating your report level publishing and report generation needs webinar header

DIA RSIDM 2022 Abstract – Lessons Learned on Document Preparation in Life Sciences

Leave a Comment / Past Webinars, Automated Report Level Publishing Resource 1 /

Regulatory submissions are one of the most critical milestones for Life Sciences organizations. Submitting on time & in full compliance with regulatory agencies’ requirements, remains a challenge. Life Sciences organizations adopt cutting-edge technology, but the technology alone doesn’t guarantee compliance & that timelines are met. Efficient processes combined with technology does.   This webinar outlines how

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The Importance of File Format Preservation in the context of Archiving

The Importance of File Format Preservation in the context of Archiving

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File Format Preservation: What is it?  File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It involves ensuring that electronic files can be read and understood by both current and future computer systems, even as technology evolves. The goal of file format preservation is to ensure

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4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)

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For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry as well as medical device knowledge. We interviewed him on 4 situations you have probably faced yourself in regulatory operations, and practical tips to overcome them. Enjoy the read! Challenges and

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Regulatory Professionals Community on LinkedIn

Leave a Comment / Blog, Audio & Video Resources 3, Automated Doc Gen Resources 3, Automated Report Level Publishing Resource 2, Incoming Email Resources 3, PDF/A & TIFF Resource 3, Submission Ready Pdf Resource 2, Validate and fix PDF Resources 3, Validate and fix Word Resources 3 /

Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many more. Join our free Accelerating eCTD submissions LinkedIn newsletter to receive monthly tips and tricks. So far, we have published: Are there any specific topics you would like to read

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Regulatory Submissions, Information, and Document Management Forum 2023 (DIA RSIDM)

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13 Feb 2023 7:30 AM –15 Feb 2023 5:30 PM Bethesda North Marriott Hotel and Conference Center5701 Marinelli Road,North Bethesda, MD 20852USA Speakers  Paul Ireland (VP Life Sciences – DocShifter) on  How to Fully Automate the Creation of Your Regulatory and other Company Reports (Session 9 Track 3: Using Automation to Replace Manual Documentation Processing,

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The Evolving State of Global Dossier Management

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Global dossier management is a hot topic for many small and large organizations in life sciences. Global dossier management is a challenging concept on its own; and people involved should be aware of multiple aspects. In our LinkedIn Live Session with Steve Gens (Managing Partner at Gens & Associates) and Preeya Beczek (Regulatory Affairs Expert

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