Scilife Blog

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.

Navigating the EU's pharmaceutical regulations can be a real head-scratcher. But there is one set of guidelines that you absolutely need to know if you are involved in manufacturing medicines in Europe. It is called EudraLex.

As one of the most regulated industries on the planet, the challenges in the pharma industry are countless, especially when it comes to managing a pharmaceutical Quality Management System.

If you’ve ever been through an audit in the life sciences industry, you know how important Corrective and Preventive Actions (CAPAs) are. Regulatory bodies expect you to have a strong CAPA process in place to uphold product quality and patient safety...

Every Quality Assurance (QA) professional knows that a Quality Management System (QMS) is the foundation of product safety and effectiveness in the pharmaceutical industry.

In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...

Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...

In the pharmaceutical industry, maintaining patient safety and product quality is not just a regulatory obligation, it’s an ethical imperative. Any oversight can lead to severe consequences, from product recalls to harm to patients, tarnishing reputa...

Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and control...

On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.

Developing medical products is no easy feat. Most of these products are highly quality-sensitive and expensive. Naturally, most companies want to work with the best experts in the field, as there is little room for error. Consulting firms have steppe...