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regulatory compliance

Here, rfxcel CEO Glenn Abood explains how serialisation software can unlock additional value beyond regulatory compliance. more

Opinion

Paolo Landriani, technical department director at SEA Vision, discusses the importance of the right equipment and software in this approach and how it can save space, improve quality and ultimately save manufacturers time and money. more

Opinion

Aflex Hose — a business division of Watson-Marlow Fluid Technology Group — has emphasized the importance of using products that are within the rules and comply with regulatory bodies’ specifications. more

Opinion

Swiss pharmaceutical group, Helsinn, has revealed it will be investing €6 million at its drug product supply centre (Helsinn Birex Pharmaceuticals — HBP) in Dublin, Ireland, to safeguard its supply chain and compliance with regulatory requirements more

News

Master data management promises an efficient, definitive way to address the demands of the forthcoming ISO IDMP standards for product information recording. What is involved in practice though, and how can companies ensure the investment pays off? more

Opinion

The Regulatory Affairs Professionals Society (RAPS) is launching its first European Council (REC) to support its expansion and to increase its presence within the region. more

News

In this online exclusive, Stuart Ward, head of Business Analysis at R&D software provider, IDBS, looks at some of the important aspects of laboratory automation that need to be considered to maintain regulatory compliance. more

Opinion

Drug delivery company, Nemera, has received drug manufacturing authorisation from the German Government Drug Administration (Government Presidium, Tübingen) for its Neuenburg plant. more

News

SecurMed UK, the non-profit organisation that will manage the UK’s Medicines Verification System, has appointed Arvato Systems to meet its obligations under the falsified medicines directive (FMD) and associated delegated regulation. more

News

A recent survey, performed by NiceLabel in cooperation with Pharmaceutical Manufacturing, has revealed the importance of a single, integrated label management system to overcome challenges encountered with producing accurate and compliant labels. more

News

According to research conducted by serialisation system provider SEA Vision and life science technology specialist Zenith Technologies, technology selection is the biggest challenge for companies preparing for serialisation regulations. more

News

Companies are putting themselves at risk by failing to appropriately prioritise and resource compliance. Here, specialist risk consultancy, Control Risks, discusses its annual research report into business attitudes towards legal and compliance risk. more

Opinion

Christoph Krähenbühl, senior director at 3C Excellis Europe, talks to EPM about Europe’s readiness for the EU falsified medicines directive (EU FMD). more

Opinion

Contract development and manufacturing organisation (CDMO), Recipharm, has delivered its first batch of serialised drug products to Saudi Arabia. This follows the introduction of new regulatory requirements in March this year. more

News

Martyn Williams, COPA-DATA UK describes how the pharmaceutical sector can get the best from technology for regulatory compliance more

Opinion

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Image: Jimmie48 Photography

Maria Sharapova has failed a drugs doping test at the Australian Open. Changes in regulations mean meldonium, once a prescription drug taken by the athlete, has now been banned more

Opinion

Unless the pharmaceutical industry manages product lifecycle data holistically in 2016, companies’ ability to achieve regulatory compliance and maintain speed to market will be compromised, warns Mark Evenepoel, Group, Amplexor Life Sciences more

Opinion

Capsugel’s Steven Facer says prioritisation of quality and regulatory compliance from the start is key to achieving long-term gains for emerging markets more

Opinion

Professor Sam Salek at the University of Hertfordshire has published a book for global regulatory agencies and the pharmaceutical industry to use when weighing up the benefits versus risks of bringing new medicines to market. more

News

Challenges of pharmaceutical regulation

Romulo Leon, head of global sales at Mettler-Toledo provides his take on fresh regulation challenges for pharma today. more

22 Oct 2014 14:14 Regulatory Affairs Blog