Pacific Strategies & Assessments’ Post

Case management software lets your organization uncover, track, investigate, and prevent almost any type of issue that affects pharmaceutical companies. Plus, Case IQ helps you identify trends and areas of risk to protect your brand, your employees, patients, and the public. Learn how 1 tool can improve your investigations in our new guide: https://lnkd.in/eSwupZUr #pharmaceuticalindustry #investigations #casemanagement #pharmaceutical

🌟 Revolutionize Your Regulatory Submissions with an upgraded boost of Technology! 🌟 Want to know how our SMART users keep pace with rapid regulatory changes? Dive into our latest blog to discover how Freyr SUBMIT PRO be the knight in shining armour to your regulatory submissions. ✨ Plus, get the scoop on the game-changing eCTD 4.0 upgrade and how AI-driven platforms like Freya Fusion are transforming compliance. 👉 Read now and stay ahead: [Link in comment section] #RegulatoryAffairs #eCTD #Pharmaceutical #RegulatorySubmissions #FreyrDigital

We are pleased to announce the launch of our Regulatory Intelligence Series, designed to provide valuable insights to manufacturing companies across all levels. Our aim is to assist in shaping effective regulatory strategies that directly influence overall business strategies. We are confident that the information shared in this series will prove instrumental in navigating the complex regulatory landscape and optimizing business outcomes. Your input is invaluable to us, and we welcome your suggestions on specific topics you would like us to cover in our upcoming releases. #pharmaceutical #regulatoryintelligence #regulatoryaffairs #regulation #buisnessdevelopment #regulatoryupdates

Few hours to go, until we go live exploring AI Document Understanding specially for Healthcare and Pharma industries. Register your seat now: https://lnkd.in/g_ysCbPp #documentunderstanding #dataextraction #pdf #pharma #pharmaceutical #healthcare #healthcaredata #medicaldata

How can pharmaceutical industry leaders navigate regulatory challenges to effectively harness the benefits of Industry 4.0 technologies? The industry's regulatory framework is heavily influenced by the complex nature of biological processes, the imperative of minimal operational errors, and the profound impact on patient health and safety. Additionally, the limited body of comprehensive scientific research on implementing Industry 4.0 technologies poses significant challenges. These hurdles include the need for extensive revalidation and regression testing of systems and conducting thorough impact analyses for sophisticated software. Let’s discuss how industry leaders can effectively navigate these regulatory waters to harness the benefits of Industry 4.0 technologies. Discover Part 5 of our 6 Barriers to Digital Transformation series now! #DigitalTransformation #Industry40 #Pharma #Biophorum #Pharmaceutical #Biopharma 

This is how we too internally share regulatory news every month in small bytes to keep our IPD colleagues in Cipla abreast with latest updates around the world. We call it internally as #CRISPTV. #cipla, #ciplaipd, #regulatoryupdates,

1 Day to go, until we go live exploring AI Document Understanding specially for Healthcare and Pharma industries. Register your seat now: https://lnkd.in/ge3dS3p6 #documentunderstanding #dataextraction #pdf #pharma #pharmaceutical #healthcare #healthcaredata #medicaldata

Here we go with 1st Video on current updates.

Here we go with 1st Video on current updates.

Submitting a #commontechnicaldocument (CTD) is a critical step in gaining regulatory approval for conducting first-in-human studies of a new #pharmaceutical product. However, it can be challenging for #biopharma companies to determine the appropriate amount of information and data needed to present compelling evidence of the drug’s safety, efficacy, and quality. Our recent blog post breaks down the top tips for providing the right amount of detail in first-in-human dossiers, including: 1. Focus on human safety when discussing manufacturing processes, controls, and reference standards 2. Share characterization and description details that support a smooth transition to human research 3. Discuss preliminary control parameters and stability assessment plans, support claims with test results Read the blog to learn more: http://spr.ly/6049Rnqbd