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ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
The water content of pharmaceuticals strongly influences their quality, shelf-life, and stability as well as the release of the active substances. The determination of water content is, therefore, vital in pharmaceutical analysis.
Lonza Pharma & Biotech is the leader in capsule-based solutions and services, proudly offering Capsugel® products.
Steriline continues to prove itself as an excellent partner for pharmaceutical companies worldwide, from now on also during earlier and more sensitive phases of drugs development.
One of the most important challenges of the hydrogen peroxide technology has traditionally been the material compatibility.
Get some hints on how you can optimize the most time-demanding steps in your lab.
The global pharma contract development and manufacturing organisation (CDMO) outsourcing market is predicted to grow.
The impact of new and alternative monitoring technologies on labor costs in the laboratory and in manufacturing can be significant.
With the increasing employment of sophisticated Data Management software, the collection and evaluation of multiple data has never been easier! However, managing such a large amount of information may represent a challenge, resulting in a potential obstacle to effective identification of the root cause of the environmental OOS associated deviation…
Release of parental drugs for injection requires test apparatus to be accurate, precise, reliable and compliant with the latest international regulation.
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
The characterization of novel therapeutics involves many chemical processes.
Would a LIMS or SAP better meet the needs of your company? That is the eternal debate for organizations who are thinking about upgrading their laboratory tracking software to a professional management system - analogous to the Mac vs PC conundrum on an industrial scale.
SGS Life Sciences offers tailored study design and testing for extractables and leachables (E&L) in finished pharmaceutical packaging, process equipment and medical devices, and leachables in final product for clients using single-use systems (SUS).
