DNV GL receives Notified Body status for Medical Devices Regulation

The Notified Body designation has been granted for all technology types

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Coronavirus: Emergency planning for the drug supply chain

The FDA has outlined its expectations and actions regarding supply chain and inspections in China

Almac Just in Time Manufacturing operations pass EU inspection

The GMP compliance certification is a significant milestone for Almac Clinical Services and its Almac Adapt

CNS Pharmaceuticals completes FDA reprocessing stipulations for API

US-based biotech has completed pilot manufacturing steps persuant to FDA pre-IND guidance for production of API for new ...

Data integrity compliance for chromatography methods

The ability to track and trace information from one laboratory to another across the globe is challenging but doable, ...

Food Standards Agency sets deadline to UK CBD industry

Businesses to apply for novel food authorisation to keep CBD oil products on shelves

PharmaLex completes regulatory compliance merger in the US

US-based Arbour Group has been acquired by German PharmaLex Group

Optimise desiccants with 3D validation software

Baltimore's CFD model brings predictive science to validation. Desiccants are tested for performance over time, ...

Brexit: UK Prime Minister sets out country’s ambitions

UK Prime Minister Boris Johnson has said he aims to reach an agreement just as good as the EU has with Canada or Japan

FDA approves peanut desensitisation treatment from Aimmune

Aimmune Therapeutics has developed Palforzia powder to help reduce the risk of anaphylaxis in children with a peanut ...

UK medical cannabis: Quality under scrutiny

Andrew James, Marketing Director of Ellutia, explains how chromatography can uncover the potency of a batch of cannabis ...

IntelGenx: Oral films are drug development’s patent trick

Exploiting improvements in bioavailability, the Canadian company has developed unique oral film technology to help ...

Printer validation packs: Don’t leave compliance to chance

Validation impacts every process and component of pharmaceutical production, including machines, systems, equipment and ...

Cannabis Trades Association: The UK should keep CBD products on shelves

A campaign is underway to prevent the Foods Standards Agency to attempt to enforce any move against the CBD industry

World’s first VR educational platform for sterile manufacturing launches

UK regulator MHRA has given a nod to new online platform Virtuosi