DocShifter

"Can you explain what it is you do?" Well, we have tried. Please let us know if you get it with a 👍 If it is unclear still, let us know as well by hitting 🤔 We will then give it another try!

DocShifter is on the move... It was Berlin 2 weeks ago, it is Paris this week. Paul Ireland is presenting our new AI capabilities around translation and redaction in regulatory at the Ennov User Meeting, and he is clearly enjoying it 😉 Thank you Olivier Pâris for the great organisation and the podium. Happy to be part of the Ennov family!

When it comes to regulatory submissions in the life sciences industry, PDFs are the backbone of communication with bodies like the FDA and EMA. But managing these documents can be a real challenge – from ensuring compliance to maintaining data integrity. In this new edition of "Document Conversion Made Easy", we are breaking down the role of PDFs in regulatory submissions, the common challenges faced, and offer practical solutions to make your life easier, including: ✅ Automated Bookmarking ✅ Document Merging & Report Generation ✅ PDF Validation & Quality Checks Enjoy the read! P.S. Don’t forget to save your spot for our upcoming webinar on optimizing Word & PDF content preparation: Link in the article. #LifeSciences #RegulatorySubmissions #RegulatoryCompliance #FDA #EMA

When we started our international DocShifter journey 6 years ago, our ambition was to improve the way people dealt with documents in regulated industries: life sciences, finance, public sector. We wanted to take away the frustration of manually dealing with documents; and make their lives easier with automation.   6 years later, here we are. Working with many inspiring and happy customers from all over the world. Every conference or event we go to, people refer to us as the chocolate guys or the LinkedIn guys or dog-shifter (thanks to our company dogs). Paul Ireland has already made a reputation for himself as Mr. PDF (patent for t-shirts is pending).   Next to all these nicknames we've been given, there is a new one we are extremely proud of.   The latest World Class RIM (sm) survey from Gens and Associates Inc. marks a new milestone in our role as innovators in the life sciences sector. We are thrilled to announce that DocShifter was recognized in this industry standard benchmark as the top ranked regulatory software provider in their innovation index that measures ‘what providers are pushing industry forward’. WOW.   Even in our wildest dream we did not hope to be in that spot.   What an honor. Thank you very, very much.   Thank you to:   - Our customers for trusting us with their valuable document conversion. - Steve Gens and his team for including us in the survey! I highly recommend you check out their benchmarks and reports; and his recent podcast. (Check out all the available podcasts here: https://lnkd.in/eUmsXjAf) - the entire DocShifter team for their hard work and dedication over the past 10 years, all of the above was only possible because of you.   I am definitely popping a cold bottle of (alcohol free) Belgian beer tonight.

LORENZ Converge is one of the most informative and engaging events in e-regulatory affairs. It’s the perfect place to hear from both industry experts and regulatory agencies all in one spot. You’ll get to dive into the latest trends, discuss best practices, and build valuable connections. Geert Van Peteghem and Paul Ireland are going to be there, too. Even better, they will not come empty-handed. Check the official event details and the insightful agenda; and reserve your Belgian comic book here. #LORENZConverge24 #regulatoryaffairs #regulatoryoperations

What are the FDA submission requirements for PDF files? To ensure the PDF is compliant, the original source documents must be prepared in a specific way. The PDF file must be: Including all content from the original source.  Readable by Adobe Acrobat X.  The correct PDF version (1.4 – 1.7 or PDF/A-1, PDF/A-2) Free from JavaScript or any other dynamic content Free from password or other restrictions.  Embedding all non-standard fonts.  Using font sizes from 9 to 12.  Free from PDF annotations Text searchable if they are scanned.  Optimized for fast web view Including table of contents if they are 5 pages or larger. These are just some of the PDF file format specifications for electronic submissions to the FDA. You can find all the FDA PDF formatting specifications in our free checklist here below.

I am excited to announce a new Podcast Series focused on key provider Regulatory Executives. First up is Ennov Founder and CEO Olivier Pâris where we discuss the recent acquisitions of Calyx Enterprise Technology division, DocShifter and Samarind along with the exciting future of Ennov. Enjoy! https://lnkd.in/e8gRgPAw

“𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐏𝐃𝐅 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐰𝐞 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐜𝐨𝐦𝐩𝐥𝐲 𝐰𝐢𝐭𝐡, 𝐢𝐧 𝐨𝐫𝐝𝐞𝐫 𝐭𝐨 𝐛𝐞 𝐅𝐃𝐀 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭?” Pharmaceutical and biotechnology companies put in a lot of work to create new medicines or products. They need to document every step of the research and development (R&D) process, which results in thousands and millions of documents. These documents come in various formats like Word, Excel, PowerPoint, text files, scanned PDFs, and image files. We have compiled a checklist to navigate regulatory teams through the PDF specifications needed to ensure full content compliance in their submissions to the US FDA. This content will help you optimize your existing FDA PDF content preparation process. Enjoy the read! #FDA #lifesciences #regulatorycompliance #regulatoryoperations

𝐀 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐆𝐮𝐢𝐝𝐞 𝐭𝐨 𝟓𝟏𝟎(𝐤) 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 (𝟐𝟎𝟐𝟒) In this new edition of "Accelerating eCTD submissions", we compiled a comprehensive guide that unpacks everything you need to know about 510(k) Submissions. - The different types of 510(k) submissions. - The 510(k) process explained step-by-step. - Common challenges of 510(k) Submission process. - Real-world applications to understand the 510(k) process in action. Enjoy the read! https://lnkd.in/ejBdve3G #FDA #regulatorysubmissions #regulatoryoperations #lifesciences