Freyr Chemicals Safety and Regulatory Affairs ’s Post

Our commitment to meeting USFDA, EU, Chinese, and other countries' regulations is unwavering. With over 300 customer audits and a production that has supported drug launches in 96+ countries, we ensure top-notch quality every step of the way! #RegulatoryCompliance #GlobalReach 🔗https://okt.to/wWq6ve 🔗https://okt.to/sOxIqY

Day 4/10: Navigating Global Regulatory Requirements 📝 The Art of Regulatory Affairs: A 10-Day Journey Bringing a product to multiple markets means understanding and complying with a variety of regulatory requirements across the globe. Whether it’s navigating the FDA, EMA, or Japan’s PMDA, each regulatory body has unique expectations. Throughout my career, I’ve learned the importance of tailoring submission strategies to meet these regional differences while maintaining a unified global approach. This can be especially challenging, but it’s a vital part of the process. How do you stay ahead of changing global regulatory requirements? 📅 Stay tuned for Day 5 tomorrow! We’ll explore post-market surveillance and its importance in regulatory affairs. #GlobalRegulatory #FDA #EMA #LifeSciences

Our goal is to streamline the pharma regulatory process, ensuring your business's success. CEBIS’s experienced regulatory consulting team excels in FDA and EMA frameworks, devising comprehensive strategies for product progression through critical milestones. We assist with post-authorization needs, product launches, line extensions, and maintaining optimal regulatory status. Our regulatory management ensures compliance with industry standards, helping develop internal policies to avoid government sanctions. #RegulatoryAffairs #PharmaCompliance #CebisInternational

🌎 **Managing Global Regulatory Licensing to Drive Compliance and Quality** 🌎 I’ve had the privilege of managing a broad scope of global regulatory licensing requirements across various regulatory frameworks, including DDA/State 3PL, FDA Tissue, NRC radioactive licenses, Japanese FMA, CAP/CLIA, ISO, and specific U.S. state tissue licenses. In this role, I ensure that our products and services meet all regulatory standards, providing guidance on complex compliance requirements and keeping our team up-to-date with emerging regulations. My focus is on building a proactive compliance culture that supports both regulatory integrity and business growth. I’m passionate about supporting healthcare innovation by ensuring every regulatory detail is met—globally and locally. #RegulatoryCompliance #GlobalLicensing #HealthcareStandards #FDACompliance #QualityAssurance #LifeSciences

🎓 Understanding US FDA Regulatory Affairs | Live Online Training | 24 April 2024 | Only £396 | During this course, you will develop effective regulatory strategies so that your product can be approved by the FDA and gain access to the US market. Learn more about the course and register here - https://buff.ly/3SVlf6s #educolifesciences #fda #regaffairs

🔍📝 Check out this article by Jack Garvey on why good manufacturing operations may have inadequate FDA inspections! Learn how to improve compliance writing and communicate effectively with regulators. https://lnkd.in/e5ZeKuGB #FDA #compliancewriting

Navigating the complex world of U.S. tobacco Regulations? Whether you're launching new products or managing an existing portfolio, understanding FDA compliance is crucial! Check out our comprehensive guide covering key registration requirements, Regulatory challenges. Freyr is here to help you every step of the way! 🌟📋 Let’s ensure your products are ready for success! 💪🏼 https://lnkd.in/dhsemDC8 #TobaccoRegulations #FDACompliance #TobaccoIndustry #MarketEntry #TobaccoProducts #NicotineProducts #RegulatoryCompliance #ManufacturingCompliance #PublicHealth #TobaccoControl #ImportExport #TobaccoTax #FreyrSolutions

Elevate Your Quality System. Envision a system that interweaves regulatory compliance with your operational DNA, transcending FDA and EMA standards. It's more than passing inspections. It's about fostering innovation, trust, safety - creating a testament to excellence where risk is a stepping stone, not a stumbling block. Wondering how to reach this zenith? Enter our expertise. We craft quality systems that are more than compliant - they're industry beacons, marrying quality and innovation. Ready to take your system beyond compliance? Let's discuss. Together, let's redefine your quality system. #pharma #medtech #quality #gmp #compliance #regulatory #zamann

Dive deep into open FDA data files to uncover valuable insights on redacted CMC reviews, post-marketing commitments, and more. Optimize your strategies and ensure regulatory compliance: Link to article: https://hubs.ly/Q02vltWw0 #ShippingValidation #PharmaSafety #FDA #ModalitySolutions

New Blog: "Preparing for an FDA Q-Sub Meeting". Read more below. #trinitymconsulting #globalconsulting #regulatory #newblogpost