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Following the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line.
Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability. Industry guidelines such as ALCOA and ALCOA+ describe these requirements, which are used by the FDA, WHO, PIC/S and GAMP. All major Metrohm software products make compliance with the ALCOA and…
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
19 September 2019 | By SUEZ
This webinar will present how to easily evaluate "fitness for purpose" of a TOC instrument for compendial water and cleaning validation applications based on USP and ICH Q2(R1).
The characterization of novel therapeutics involves many chemical processes.
The seven centres will aid disease research and clinical development, improving access to patient data for studies.
According to a new report, blockchain technology in the healthcare market size is set to increase exponentially.
Research has found that the worldwide LC-MS market will be worth $2750 million by the end of the forecast period in 2024.
The possibilities presented by real-world data to improve drug development processes could enhance regulatory and pricing decisions for new therapeutics.
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…
We’re getting closer to something special with regard to how we manufacture biopharmaceuticals. Loe Cameron explores where the continuous bioprocessing journey could take us and what it might mean for medicine manufacturers worldwide.
All therapeutic developers and manufacturers are under intense pressure to improve efficiency and productivity and reduce costs, all while maintaining the highest quality standards.
Confirming product authenticity, combating counterfeiting and preventing product diversion are key for compliance within the global supply chain. This whitepaper focuses on pharmaceutical serialisation and solutions to combat producers of counterfeit products.
Positron emission tomography (PET) is a popular nuclear imaging technique used to gain information about specific metabolic functions.
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.
