DocShifter’s Post

𝐒𝐭𝐨𝐩 𝐰𝐚𝐬𝐭𝐢𝐧𝐠 𝐭𝐢𝐦𝐞 𝐰𝐡𝐞𝐧 𝐩𝐫𝐞𝐩𝐚𝐫𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬. ⛔ Imagine this... An ideal world where you can ditch the countless hours spent manually preparing documents for submissions – no matter the volume (50 or 5,000) or the health authority (US FDA, HC, EMA, etc.). 𝐖𝐡𝐚𝐭 𝐢𝐟 𝐲𝐨𝐮 𝐜𝐨𝐮𝐥𝐝 𝐚𝐜𝐡𝐢𝐞𝐯𝐞 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞, 𝐢𝐧 𝐣𝐮𝐬𝐭 𝟑 𝐜𝐥𝐢𝐜𝐤𝐬? 3-click compliance is like having a super simple way to make sure all your documents meet regulatory standards. With just 3 clicks, you can turn complicated content preparation tasks into something really easy. Making it quick and hassle-free to create compliant documents in seconds. 𝐇𝐞𝐫𝐞's 𝐡𝐨𝐰 𝐢𝐭 𝐰𝐨𝐫𝐤𝐬: 1. Select your Word or PDF documents (for US FDA submission, for example). 2. Drag and drop them into a web browser. 3. Within seconds, you'll have a fully FDA-compliant PDF ready to go! This is 𝟑-𝐜𝐥𝐢𝐜𝐤 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞! (or as you might call it, "winning back valuable time" or "effortless document prep"). 😎 #regulatorycompliance #regulatorysubmissions #lifesciences

𝗥𝗼𝗹e 𝗼𝗳 𝘄𝗿𝗶𝘁𝗲 𝘂𝗽 𝗶𝗻 𝗗𝗼𝘀𝘀𝗶𝗲𝗿 𝗽𝗿𝗲𝗽𝗮𝗿𝗮𝘁𝗶𝗼𝗻 In the preparation of a dossier, a write-up plays a crucial role as it provides detailed information about various aspects related to the subject. Here's a breakdown of its significance: Introduction: The write-up introduces the dossier, providing an overview of its purpose, scope, and contents. It sets the tone and prepares the reader for what to expect. Like: description and composition of FP. Background Information: It includes relevant background information about the subject matter, such as historical context, key events, and any pertinent data or statistics. Summary of Findings: The write-up summarizes the main findings or key points presented in the dossier. This helps to highlight the most important information and provides a quick overview for the reader. Like: bookmarks of each dossier section Analysis and Interpretation: It may include an analysis and interpretation of the data or information presented in the dossier. This helps to provide insights and context, helping the reader understand the significance of the findings. For: prepare of table of the excipient and his grades and reference Copeia. Recommendations or Conclusions: The write-up may include recommendations or conclusions based on the findings presented in the dossier. This helps to guide decision-making and action based on the information provided. References or Citations: If applicable, the write-up may include references or citations to sources used in the preparation of the dossier. This helps to provide credibility and allows readers to further explore the topic if desired. Like : add a reference on modules 4 and 5 in case of waiver and BE and NDA also Overall, the write-up serves as a critical component of the dossier, providing context, analysis, and recommendations that help the reader understand and make use of the information presented. #Dossier #CMC #regulatoryaffairs #regulatory #regulatorycompliance #regulatorystrategy #regulatorychallenges #regulatoryrequirements #pharma #regulatoryintelligence #drugs #regulatoryrequirements #regulatoryexcellence #pharmacompanies

𝐒𝐭𝐨𝐩 𝐰𝐚𝐬𝐭𝐢𝐧𝐠 𝐭𝐢𝐦𝐞 𝐰𝐡𝐞𝐧 𝐩𝐫𝐞𝐩𝐚𝐫𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬. ⛔ Imagine this... An ideal world where you can ditch the countless hours spent manually preparing documents for submissions – no matter the volume (50 or 5,000) or the health authority (US FDA, HC, EMA, etc.). 𝐖𝐡𝐚𝐭 𝐢𝐟 𝐲𝐨𝐮 𝐜𝐨𝐮𝐥𝐝 𝐚𝐜𝐡𝐢𝐞𝐯𝐞 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞, 𝐢𝐧 𝐣𝐮𝐬𝐭 𝟑 𝐜𝐥𝐢𝐜𝐤𝐬? 3-click compliance is like having a super simple way to make sure all your documents meet regulatory standards. With just 3 clicks, you can turn complicated content preparation tasks into something really easy. Making it quick and hassle-free to create compliant documents in seconds. 𝐇𝐞𝐫𝐞's 𝐡𝐨𝐰 𝐢𝐭 𝐰𝐨𝐫𝐤𝐬: 1. Select your Word or PDF documents (for US FDA submission, for example). 2. Drag and drop them into a web browser. 3. Within seconds, you'll have a fully FDA-compliant PDF ready to go! This is 𝟑-𝐜𝐥𝐢𝐜𝐤 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞! (or as you might call it, "winning back valuable time" or "effortless document prep"). 😎 #regulatorycompliance #regulatorysubmissions #lifesciences

Cross collaboration from the start of design and development is essential!

😡 Quality and regulatory affairs should be involved from the start of the design project. Here's a key example: →When building your URS, if you haven't considered the GSPRs (Annex I (EU) MDR 2017/745), there's a high chance of unpleasant surprises at the project's end... Depending on your organization's size, you might work in a development team, which I find most effective. This allows for: →A technical perspective from the R&D team →A quality view for proper document writing →A regulatory perspective for compliance with (EU) MDR 2017/745 It's rare for one person to have a broad enough view to consider all project aspects (technical, regulatory, documentation, etc...) That's why collaboration is necessary from the beginning, with each contributing their knowledge for the project's advancement. PS: We love you R&D team, we're not here to restrict you. If you want to evaluate your design & development process according to ISO 13485:2016, here's our book with 365 questions to evaluate your QMS, including a list of expected evidence! Perfect for quick audits and addressing potential non-conformities. 📗365 questions to evaluate your QMS : https://lnkd.in/gTMAQRHp

A warm thank you to everyone that made our '3-click document compliance for CRO & Regulatory Service providers' a success last week. Thank you for your questions and interaction. There were multiple questions about bookmarks. To be more specific, whether it is possible to automatically create a bookmark structure in PDFs where no bookmarks are present in the source document. With DocShifter, the answer is yes. Here is a short video from our 3-click document compliance webinar; showing you the: - how - what - results Go for a much faster, efficient PDF preparation process for your regulatory submissions. #regulatorycompliance #PDF #lifesciences #regulatorysubmission

A warm thank you to everyone that made our '3-click document compliance for CRO & Regulatory Service providers' a success yesterday. Thank you for your questions and interaction. There were multiple questions about bookmarks. To be more specific, whether it is possible to automatically create a bookmark structure in PDFs where no bookmarks are present in the source document. With DocShifter, the answer is yes. Here is a short video from our 3-click document compliance webinar; showing you the: - how - what - results Go for a much faster, efficient PDF preparation process for your regulatory submissions. #regulatorycompliance #PDF #lifesciences #regulatorysubmission

“In a case where we want to submit to one or multiple health authorities, how does this 3-click document compliance work exactly?” Many regulatory teams generate ICH-specific PDF renditions first, and then manually tweak those PDFs to meet the FDA, PMDA, EMA, etc. requirements. There’s nothing wrong with this method. Everyone in regulatory operations, or anyone responsible for formatting documents, is in one way or another familiar with this process. Here's the limitation, though: You can only do this document per document, or wait until the publishing stage (almost like the very last minute). What if your PDFs contains errors, though? This makes your job even more difficult; because you would have to go back, find the source document(s), fix the errors and publish them again. 3-click compliance with DocShifter is a much more efficient process, whether you generate compliant PDFs for 1 or multiple health authorities. I'll quickly explain. 1. Select Word or PDF documents you want to include in a Japan PMDA submission 2. Drag & drop these documents into a web browser 3. Get PMDA compliant output returned in a matter of seconds. With the correct bookmarks, hyperlinks, font settings, optimized for fast web view, etc. In the example video, I used a PMDA workflow. You can use as many workflows as you want in the background; allowing you to generate region-specific output based on the same source document. Handy, is it not? #automation #lifesciences #pdf #regulatorycompliance

Navigating FDA's eSTAR Version 4.3: A Balancing Act Between Efficiency and Compatibility As the medical device industry embraces digital transformation, the FDA’s eSTAR program's latest update to Version 4.3 represents a significant shift. While eSTAR enhances the 510(k) submission process, ensuring electronic compliance for Class II submissions, it brings its own set of challenges, particularly in terms of software compatibility and performance. A common issue faced by many is the slow performance of Adobe Acrobat Pro, the recommended software by the FDA. Users often experience delays, with the software taking several seconds to a minute to respond to each entry and selection. This sluggishness can significantly hamper the efficiency of preparing a submission, leading to frustration and potential delays in meeting critical regulatory timelines. In search of speedier alternatives, some have turned to another PDF editing software that is recommended by the FDA; PDF XChange Editor. This software offers a much faster user experience, drastically reducing the time spent on each action. However, this solution isn't without its drawbacks. A major hurdle is the compatibility issue with Adobe Acrobat Pro. eSTAR submissions prepared or edited in PDF XChange Editor often encounter issues when later opened in Adobe, leading to inconsistencies and potential submission errors. This situation underscores the need for expert guidance in the 510(k) submission process. With eSTAR Version 4.3 mandating electronic submissions for most Class II devices, the stakes are higher than ever. The right regulatory consultant can provide invaluable insights into not only navigating these software challenges but also ensuring that your submission is compliant, efficient, and effective. At Fang Consulting, we understand these nuances and are equipped to help our clients navigate the complexities of eSTAR submissions. Our team stays abreast of the latest updates and best practices, ensuring that your 510(k) submissions are not only compliant but also optimized for a smooth review process. From software selection to strategic regulatory advice, our goal is to streamline your FDA submission process, mitigating any potential setbacks. Partner with us at Fang Consulting for a seamless journey through the FDA's regulatory landscape. ➡ www.fangconsulting.com Information provided by Isaac Erickson, MBS

Enhance your regulatory publishing and submission process with G&L. Our expert support ensures a streamlined approval journey. Connect with us today to discover how we can expedite your success. View our Case Studies: https://lnkd.in/eG9JvstP #RegulatoryPublishing #RegulatoryAffairs #QualityAssurance #ClinicalDevelopment