Scilife Blog

A foundational aspect of quality assurance in the life sciences industry is being able to trust the data collected during all lifecycle stages of a pharmaceutical or medical device product, from R&D and clinical development through commercializat...

If you have spent any time on a manufacturing floor, you know the feeling that kicks in when you hear an inspector has just signed into the lobby. I remember my first major site audit vividly. I had spent three weeks checking every single machine mai...

Finding the best compliance tools for pharmaceutical companies is now a survival requirement for any QARA professional overseen by increasing regulatory complexity and global supply chains. In this post, we’ll explain why pharmaceutical regulatory co...

If you’re a professional in pharmaceuticals, biotech, advanced therapy medicinal products (ATMPs), or medical devices operating in the UK, you know the gravity of an inspection conducted by the Medicines and Healthcare products Regulatory Agency (MHR...

Today, Good Laboratory Practices in the pharmaceutical industry remain the foundation of reliable science, ensuring that non-clinical data used for regulatory submissions is both credible and reproducible.

When your manufacturing line is running smoothly and your paperwork looks in order, you might think you’re “doing GMP”.

If you're in pharmaceutical development, Quality by Design (QbD) is a term you know well. It represents an advancement in how we develop and manufacture medicines, and at its heart is the ICH Q8 guideline.

Thanks to the growing use of AI in drug development, pharmaceutical companies can now sift through all that data to spot patterns, predict failures, and make better decisions faster. From finding promising drug candidates to optimizing clinical trial...

The pharmaceutical industry is under more pressure than ever. Regulatory demands are tighter, production timelines are shorter, and data is more complex. Add global teams and supply chain volatility, and you've got zero room for error.

From Lab bench to market: Navigating biotech and pharma Ever wondered what really sets biotech apart from pharma? They're often lumped together, but these two powerhouses of human health take radically different routes to get from concept to cure. Fr...

In the life sciences, compliance is everything, and two of the most critical regulations are Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP).

We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system.