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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.
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.
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.
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
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.
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
The global generics drug market is anticipated to grow to $574.63 billion by 2030, owing to the increasing application of robotic process automation, branded medicine patent expiries and the rising prevalence of chronic diseases.
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
