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Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading thi...

21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...

Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why Quality professionals in the pharma industry actively seek to understand the details of cGMP regulations. In most cases, they also...

On October 20, 2022, I had the unique opportunity to attend Evgeniya Makarova‘s virtual talk at Scilife’s Smart Quality Summit. I must admit: I was very excited to listen to her speech. I even bought brand-new white AirPods for the occasion! As a pas...

510K and Premarket Approval are both feasible routes for filing a medical device application in the USA. Similar to other US FDA regulatory frameworks, the applicability of the 510K (also known as Premarket Notification) and Premarket Approval is dec...

Implementing a Quality Management System is key to ensuring consistency in all your processes and, ultimately, guaranteeing your product quality and safety. A well-established QMS will allow you to meet both customer and organizational requirements, ...

Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...

Like any other regulated product, your medical device must be properly labeled. But do you know how to prepare a medical device label and which regulations your label has to comply with? And how about which ISO standards can help you meet these regul...

Why GAMP 5 Needed a 2nd Edition GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP Computer Systems in regulated industries – including the Life Sciences. Recent technologi...

It seems like everything around us is turning ‘Smart’. Usually, that refers to objects like cars, appliances, and wearables being digitized, connecting to your devices, or operating with A.I. capabilities. ‘Smart’ can also allude to integrating with ...

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to learn mor...

In addition to meeting rigorous safety requirements, medical device manufacturers must also comply with strict quality standards. That is why a compliant Quality Management System (QMS) is fundamental to any Life Sciences company operating in the tig...

What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...