What Is EU CTR Submission?
EU CTR submission means sending in clinical trial applications under the rules set by the European Union Clinical Trials Regulation (EU CTR 536/2014). This regulation covers how clinical trials for medicines get approved, run, and overseen in EU countries.
What is Permitted Daily Exposure (PDE) Calculation
At Masuu Global, patient safety is the central focus of pharmaceutical manufacturing and quality control. As companies increasingly use shared facilities to produce multiple products, the risk of cross-contamination becomes a major concern.
How to read a CEP – European Directorate for the Quality of Medicines(EDQM)
Overview:- Aim and scope of EDQM policy document PA/PH/CEP(15)31 “How to read a CEP”
- How to interpret the information laid down on CEPs
GxP Regulatory Compliance Audits: Ensuring Excellence Across the Entire Quality Framework
In the tightly regulated world of pharmaceuticals, biotechnology, and life sciences, compliance, it’s the bedrock of product integrity, patient safety, and the overall continuity of business operations. As organizations navigate increasingly complex landscapes, sticking to the full spectrum of GxP (Good Practice) standards becomes crucial.
Pre-Health Authorities Mock Audit: Ensuring Confidence and Readiness for Regulatory Inspections
In the pharmaceutical, biotechnology, and life sciences industries, inspections by health authorities like the FDA, EMA, MHRA, WHO, and local agencies are pivotal moments.