Certara’s Post

Are you ready for eCTD 4.0? Don't get left behind! Join our webinar to explore the new submission structure of eCTD 4.0 and discover how the right software can make the transition to eCTD v4.0 easy. Register now: https://lnkd.in/eZcgPcjK #eCTD #cloud #software #technology #regulatory #submissions #lifescience #regulatoryaffairs #regops #regulatorytechnology #regulatorycompliance #pharmaceutical #efficient #EMA #FDA

𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 𝗥𝗲𝗴𝗶𝗼𝗻𝗮𝗹 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗚𝘂𝗶𝗱𝗲 𝗳𝗼𝗿 𝗘𝟮𝗕 (𝗥𝟯) 𝗲-𝗧𝗿𝗮𝗻𝘀𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗼𝗳 𝗜𝗖𝗦𝗥 𝗮𝗻𝗱 𝗣𝗿𝗼𝘃𝗶𝗱𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝗶𝗻 𝗘𝗹𝗲𝗰𝘁𝗿𝗼𝗻𝗶𝗰 𝗙𝗼𝗿𝗺𝗮𝘁: 𝗜𝗡𝗗 𝗦𝗮𝗳𝗲𝘁𝘆 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 Guidance: https://lnkd.in/eKPngD7b This FDA guide explains how to electronically submit reports on side effects of various medications to the FDA. It covers a broad range of drugs, including prescription and over-the-counter medications, as well as biological products. Beyond specifying what to report, the guide focuses on the technical aspects of electronic submissions, ensuring consistent formatting and data collection that meets the FDA's specific requirements. This streamlined process allows healthcare providers, researchers, and even patients to contribute to the FDA's database on medication safety. Contact  BIOBOSTON CONSULTING today or visit our  website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda  #quality #compliance #qualityassurance #regulatoryaffairs

#Statistics for the #pharmaceutical industry? Then you need a statistical software that is seriously compliant with FDA guidelines. No worries, we have that software! It's TIBCO Statistica. Take a look here on StatSoft GmbH website: https://lnkd.in/dvrVhrzN #alternativeToMinitab #qualityByDesign #stabilityStudy #pqr #qualityAssurance

📣 ICYMI: Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. 🔍 The data is out there, let's use it and learn from it. https://wix.to/PadqUjC #newblogpost #qualitysystems #quality #meddevice #pharma

📣 ICYMI: Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. 🔍 The data is out there, let's use it and learn from it. https://wix.to/PadqUjC #newblogpost #qualitysystems #quality #pharma

United Pharma Tech (UPT) recognizes the far-reaching impact of the FDA's Final Rule on Laboratory-Developed Tests (LDTs) in the Pharmaceutical and Life Sciences sectors. As regulatory oversight increases and laboratories adapt to new compliance protocols, patient safety remains paramount. UPT specializes in navigating healthcare regulations and offers tailored staffing solutions to support your organization through this transition. Connect with us to explore the implications of these regulatory shifts and address your staffing needs effectively. #LaboratoryServices #HealthcareRegulations #LifeSciences #PharmaceuticalIndustry #MedicalResearch

You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity

You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity

Navigating Regulatory Landscapes with Expert Regulatory Intelligence 🌐 At Clini Resource, we specialize in Regulatory Intelligence (RI) services, providing essential insights to navigate the complex regulatory environments in the pharmaceutical industry. Our team closely monitors global regulatory changes, industry trends, and compliance requirements, ensuring that your products meet all necessary standards and guidelines. Stay ahead of the curve with Clini Resource's comprehensive RI services, designed to support informed decision-making and strategic planning. For more details: 📧 info@cliniresource.com 🌐 www.cliniresource.com #RegulatoryIntelligence #PharmaCompliance #DrugDevelopment #HealthcareRegulations #PharmaIndustry #CliniResource

#BIO2024 is a wrap for the team at Facet Life Sciences! We met with many small organizations that recognize the importance of taking an integrated services approach to development. Facet Life Sciences is a team of clinical, nonclinical, CMC, FDA regulatory, biostats, and commercialization experts focused exclusively on the success of small organizations. An essential part of any development plan is finding the right regulatory partner. The agency is constantly evolving and changing in ways that could present new opportunities or significant challenges. FDA interactions are a routine part of our business: - we engage often with CDER, CBER, and CDRH - we prepare and submit 15+ IND's for sponsors annually  - we meet formally with FDA on average every 3 weeks - we average 15+ years industry experience per employee - we communicate with FDA (most divisions) daily At Facet, we're focused exclusively on helping small organizations design and implement lean and effective strategies for getting to and through FDA successfully. If we missed you at #BIO2024, get in touch and learn how we can help you achieve your development goals! #regulatoryservices #regulatory #clinical #pharmaceutical #biotechnology #fda #fdacompliance #facetlifesciences