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Ensure the integrity of your life sciences operations. Proper validation safeguards against costly delays, regulatory non-compliance, and potential product recalls. Discover our reliable validation solutions today. #lifesciences #validation #compliance #regulatory #qualityassurance

Understanding the FDA's Final Rule on LDTs can be overwhelming for many manufacturers. Our team has broken down the key changes and deadlines to help you navigate these new requirements. If you need expert guidance on complying with the FDA's Final Rule on LDTs, review our comprehensive overview below. LDT manufacturers seeking assistance in understanding and implementing these regulatory changes can rely on Rook Quality Systems for support! #LDT #FDA #Regulatory #Compliance #LookToRook

Here is the summary of the final rule on Laboratory-Developed Tests (LDTs). #FDA #LDT #IVDs #Regulations

Interesting Blog Article from the FDA, written by some of the team at Hyman, Phelps & McNamara, P.C. Take a few minutes and read on ... Blog article here ➡️ https://lnkd.in/g3NyjUiY #QLeaRadvisors #QLeaRcares #mlv #TalkToMeTuesday #FDA #FDAcompliance #FDAlaw #quality #regulatory #compliance

Specialising in Regulatory affairs and innovative devices, MnandiPharma centers itself within a host of services including importing & exporting, registration, distribution and manufacturing. #medicaldevices #compliance #regulatory #Logistics #newbusiness

Specialising in Regulatory affairs and innovative devices, MnandiPharma centers itself within a host of services including importing & exporting, registration, distribution and manufacturing. #medicaldevices #compliance #regulatory #Logistics #newbusiness

Day 2/10: Key Differences Between US and EU Regulatory Frameworks 📝 The Art of Regulatory Affairs: A 10-Day Journey One of the biggest challenges for global product developers is navigating the differences between the US and EU regulatory frameworks. From the FDA’s focus on pre-market approval and clinical trials to the EU’s emphasis on CE marking and post-market surveillance, understanding these variations is essential for a smooth product launch. In my experience, knowing these differences early in the development process can save time and resources down the line. What strategies do you use to manage multi-region regulatory compliance? 📅 Stay tuned for Day 3 tomorrow!We’ll cover best practices for preparing regulatory submission dossiers. #RegulatoryCompliance #FDA #CE

Regulatory compliance starts with precision. Learn why accurate translations of GMP and CMC documents are key to life sciences success in global markets. https://lnkd.in/e_cGGAfQ #RegulatoryCompliance #LifeSciencesLocalization

I hope this blog article doesn't offend any of my fellow consultants or eQMS partners, but I've always been critical of over-stuffed Quality Manuals, and with the upcoming FDA QMSR alignment with ISO 13485 it will become a requirement for all FDA-regulated device companies. I keep seeing postings offering to solve the problem with templatized, one-size fits all Quality Manuals, and every one of them is guilty of overthinking the 13485 requirements and intent. You don't actually think any of your employees actually read your 20, 30, 40+ page Quality Manual, do you? #QRxPartners #QRxInforms #QualityManual #QMS #MLV #QMSR #FDA #ISO13485