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The constantly updated regulations, demand for global formats, and upsurge of data requirements question the methods in which Regulatory information is being managed.   With technologically advanced architecture integrated with ever-evolving Regulatory standards, Freyr SPAR maintains information – from tracking product registrations, marketing authorization lifecycles, product data, Regulatory document management, and HA interactions to generating reports with a zero-footprint viewer. Don’t wait to find out more, Contact us today! https://lnkd.in/dujaJcrb #FreyrDigital #Pharmaceuticals #Biotechnology #RegulatoryAffairs #RIMS

Meet the Agility Integra! Our new, fully automated ELISA system pairs #speed, #precision, and #flexibility with enhanced data #integrity and #security for the #pharmaceutical and #biotechnology markets. Learn how to achieve powerful lab proficiency: https://bit.ly/3Q78hTe #highthroughput #labautomation #compliance #21CFRPart11

Are you curious about the FDA's new advanced manufacturing program for drugs and biologics? The pharmaceutical industry is welcoming the initiative but clamoring for clarity on crucial details. What manufacturing methods will be covered? Which sponsors can participate? How quickly will it work? Key players like PhRMA, BIO, and ISPE submitted comments voicing concerns and asking for more information on: ✅ The scope and eligibility criteria ✅ Data requirements for proving quality improvements ✅ Separate guidance for biologics and complex products ✅ Interaction with existing FDA programs While the program aims to speed up adoption of innovative manufacturing tech, there are still many open questions about how it will operate in practice. Check out the full article here: https://buff.ly/3VJtSV3 #pharma #biotech #manufacturing #data #digital #ai #technology #digitaltransformation #software #IoT #automation #information #knowledgemanagement #drugdevelopment #implementation #IT #OT #PLM #dataintegrity

This is a great recap of the acceptance of in silico evidence by regulatory bodies in the pharmaceutical industry. It is in line with the article I wrote about the digital evidence acceptance in medical device industry. Great to see the in silico technology growing from the regulatory side!

Over the past 2 days at the PDA - Parenteral Drug Association Asia Pacific Regulatory conference, there were good discussions on the increasing focus on use of quality risk management and AI/ML. The following article from Outsourced Pharma on the things the regulated industry needs to focus on in 2024 reflects the same sentiments. Another point to note in this article, is the need for drug development companies to begin thinking and strategising about quality systems from the early stages. #qualitymanagementsystem #drugdevelopment #biotech #riskmanagement #artificialintelligence #machinelearning

𝐓𝐡𝐞 𝐆𝐥𝐨𝐛𝐚𝐥 𝐖𝐚𝐯𝐞 𝐨𝐟 𝐈𝐧 𝐒𝐢𝐥𝐢𝐜𝐨 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 🌏💊 With regulatory bodies around the world #recognizing and #accepting in silico modeling and simulation as a valid approach for regulatory compliance, many more government regulatory agencies are expected to follow suit and embrace these innovative computational approaches. This widespread adoption opens up exciting #opportunities for pharmaceutical companies to leverage in silico, streamline their drug development processes, and bring #safe and #effective therapies to market more efficiently. 💻   ✨ InSilicoMinds, a leading provider of advanced in silico modeling and simulation solutions, is well-positioned to #support your organization in navigating this rapidly evolving landscape. 👨🔬 Our team of experts have decades of experience in generating model informed evidence to support #drugdevelopment and #regulatory compliance. By partnering with us, you can gain a competitive edge, #accelerate your drug development timelines, and ultimately improve patient outcomes #worldwide. InSilicoTrials #InSilicoModeling #ModelingAndSimulation #PharmaceuticalInnovation #DrugDevelopment #RegulatoryAffairs #PBPK #QSP #DataScience #ArtificialIntelligence #PrecisionMedicine #LifeSciences #Biotech #Pharma

"If I am looking at a more global combination product program, how are things different between the United States regulation and other territories?" "What should I be aware of as I enter various territories?" "What should I consider when developing a global regulatory strategy for my drug delivery device system?" These are common questions we hear from clients who are exploring global markets. If you are considering a multi-territory approach to your combination product, check out answers to these questions in our ever-growing "How to build a successful combination product program" article: https://lnkd.in/guD3z4Vs #globalregulatorystrategy #regulatoryaffairs #combinationproduct #drugdeliverysystem #deliverydevice #medtech #pharma #biotech

Compliance is important in all industries, but perhaps none more so than pharmaceutics 💊 Find out how Charles River Laboratories is using OrbusInfinity to improve compliance and meet regulatory requirements, all while reducing costs ⬇️ https://lnkd.in/eezR-BbV #EnterpriseTransformation #EnterpriseArchitecture #Pharma #Compliance  

Getting the right team in place is critical to drug delivery device development success. Check out this article for human resources-related answers to the most common questions we hear from your industry colleagues. And keep checking back weekly as we expand topics!

Environmental control is important for reliable inhaler testing. If you want to know why, and more importantly how to achieve it, then we have new literature to help. Our white paper explains the mechanisms by which temperature, relative humidity, and electrostatics influence inhaled product performance and test data. The companion application note demonstrates how EnviroMate™, a benchtop environmental chamber, can help solve the problem. Both are a great read.  ⬇ Download them here: 📝 White paper - https://lnkd.in/gS7h7AbB 📝 Application note – https://lnkd.in/g7SacQSn #InhalerTesting #OINDPs #Pharmaceutical #Pharma #Formulations #Innovative #Compliant #Trusted