Eurofins PSS Insourcing Solutions® (PSS) employs and manages full-time scientists, managers and support staff to perform a defined scope of work at a client’s facility.
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Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
Articles in this in-depth focus discuss the challenges facing advanced therapy medicinal product developers and which leadership qualities could be implemented to drive innovation in biologics.
In this in-depth focus explore the implications of Trump's 'Buy American’ order for drug manufacturers, how researchers step-up metformin production from lab to industry scale and a discussion on how advanced planning could enable pharmaceutical production to be scaled up.
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
Read articles on validating rapid microbial methods according to regulatory requirements and how solid-state NMR spectroscopy can be used to analyse pharmaceuticals in this in-depth focus.
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Eurofins Scientific, SGS Life Sciences, Charles River Laboratories, ACCI, Eurofins Amatsi Group and Thermo Fisher Scientific showcase their unique outsourcing services and discuss how they stand out from the competition.
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
EPR’s Hannah Balfour discusses some of the proposed COVID-19 vaccine distribution plans and how medicinal nationalism and supply deals could prevent “fair and equitable access” to COVID-19 vaccines.
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
AJ Ploszay, IQVIA’s Vice President of Digital Strategy, discusses how COVID-19 has accelerated digital transformation and driven the adoption of digital detailing.
Christoph Krähenbühl outlines five considerations for virtual pharmaceutical companies when launching a new drug product.
Helen Farr, a Partner at Taylor Wessing, discusses the hurdles that life science businesses must tackle to bring employees back to work safely; whether that be working remotely or returning to the lab.