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Application note: Taxonomic traceability for bacterial and fungal entries in Accugenix® reference databases
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
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Regs & Legs
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Whitepaper: UDI – from the basics to the benefits
Get the most detailed information about UDI – requirements, implementation and benefits. Everything that supply chain participants need to know!
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Product hub: 3P® connect EM-BODY connectivity
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
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The registration of novel excipients
Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
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EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
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Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
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Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
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Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
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Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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Whitepaper: The new age digital contract research organisations
The ideal CRO digital platform offers an opportunity to un-burden bureaucracy and drive data capture and integrity straight into the digital eco-system allowing earlier intervention.
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UK regulator publishes guidance on use of real-world data to support clinical trials
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
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European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
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EMA launches the Regulatory Science Research Needs initiative
The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.
