Blogs

Clinical Trials Managing 300x225 - Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations Posted in: Achieving Regulatory Compliance, Blog, Clinical Trials, Operations & Labeling, Regulatory & Compliance - The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component…
Clinical trials when 300x225 - Clinical Trials: When the Label became more Significant than the Drug Itself… Clinical Trials: When the Label became more Significant than the Drug Itself… Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Clinical Trials, Pharmaceuticals, Reducing Risks, Regulatory & Compliance, Supply Chain - The importance of labeling in clinical trials gets very little exposure. However, as the global war for patients intensifies in…
Vials in Clinical Trials Top Three Challenges in Clinical Trial Packaging and Labeling Operations Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Clinical Trials, Increasing The Operational Efficiency, Operations & Labeling, Project Managers, Supply Chain - During our recent webinar ‘Future proofing your Clinical Supply Chain’, co-presented by myself and Jason James, Senior Manager, Labelling &…
Medical Device FDA 21 CFR PART 11 Posted in: Blog, Business Analysis, Medical Device, Regulatory & Compliance - FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place…
EUROPEAN MEDICAL 300x225 - What is the European Medical Device Regulation – EU MDR? What is the European Medical Device Regulation – EU MDR? Posted in: Blog, Medical Device, Regulatory & Compliance - The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in…
Medical Device What is the Unique Device Identification – UDI? Posted in: Blog, Medical Device, Operations & Labeling, Regulatory & Compliance - The FDA’s Unique Device Identification (UDI) of medical devices aims to offer a practical solution to display standard product information…
Medical Device UDI: FDA Draft Guidance Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Medical Device, Operations & Labeling, Regulatory & Compliance - The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form…
Leveraging 300x225 - Leveraging Your Supplier Leveraging Your Supplier Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Clinical Trials, Medical Device, Operations & Labeling, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain - Leveraging your supplier is one of the five key principles of the GAMP 5 ‘Risk-based approach to compliant GxP computerised…
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