EU MDR Compliance: A Complete Guide to CE Marking for Medical Devices
Building a great device is only half the job if you want to sell in Europe. Before a product reaches the market, manufacturers have to prove it’s safe and well made. That’s where EU MDR compliance comes in. The Medical Device Regulation (EU) 2017/745 spells out exactly what a manufacturer needs to demonstrate before a device can carry the CE mark.CTD vs eCTD: Key Differences in Pharmaceutical Regulatory Submissions
CTD versus eCTD is a decision for pharmaceutical companies who are preparing regulatory submissions for new medicines and for products already on the market. Both CTD and eCTD help organise documentation for regulatory review yet they differ in how the information is submitted and how it is managed. Knowing the differences between CTD and eCTD lets companies choose the approach for the regulatory authority and the market they target. I think this knowledge is essential for any team handling submissions.
What Is a GxP Compliance Audit? Types, Scope, and Benefits
A GxP compliance audit helps pharmaceutical and life sciences companies check whether their operations follow applicable Good Practice (GxP) requirements.
Predicted Environmental Concentration (PEC): Calculation, Purpose, and Interpretation
Predicted environmental concentration PEC is an important parameter in pharmaceutical Environmental Risk Assessment (ERA), used to estimate the concentration of a pharmaceutical substance expected to enter the environment.
How to Prepare for a Pharmaceutical GMP Audit: Step-by-Step Guide
GMP audit preparation helps pharmaceutical companies check whether their manufacturing processes, quality systems, and records meet Good Manufacturing Practices (GMP) requirements. It also helps teams find compliance gaps before an audit.