Scilife Blog

Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.

It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...

Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.

Pharma 4.0 is a framework for incorporating digital strategies into pharmaceutical manufacturing contexts. This framework envisions a manufacturing paradigm that allows manufacturers to change and iterate, connect resources and workers, simplify comp...

In the history of civilization and economic development, several industrial revolutions have brought about profound paradigm changes in society, economics, and culture, reshaping industries, creating new opportunities, and raising living standards fo...

The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...

Regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are undergoing significant changes to meet the challenges and opportunities posed by this technology.

The pharmaceutical industry is rapidly evolving, and the number of AI application integrations is increasing day by day, reshaping every facet of pharmaceutical processes from drug discovery to supply chain management.

This is a story of triumph over tragedy. A story shaped by pivotal events that stress the importance of regulatory oversight in the production of pharmaceuticals and other medical products. This is the story of how the Good Manufacturing Practices (G...

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 this post to ...

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.