Latest Articles

  • Quality: The Gold Standard for CDMOs - No Exceptions, No Compromises

    In today’s hyper-competitive pharmaceutical landscape, innovation, speed-to-market and cost control usually take the spotlight when selecting a contract development and manufacturing organization (CDMO). However, underneath all those metrics, a single truth remains: if quality fails, so does everything else. read more

  • Future-Proofing Pharmacovigilance in an AI Era

    Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event reports, and respond to heightened scrutiny from both regulators and the public. read more

  • PV Automation Next Steps: Solving the Significant Headache of Local Literature Monitoring

    Medical literature monitoring is a key part of pharmacovigilance (PV) and ultimately patient safety across the lifecycle of a medicine. Globally, the practice is relatively straightforward, but up to now, screening local literature has been a highly resource-intensive activity yielding modest, if vital, findings. That smart automation might alleviate the burden comes as a huge relief, especially as product development ambitions grow and PV process innovation becomes essential to control costs. Biologit’s Jean Redmond explains. read more

  • Challenges in Developing Analytical Procedures with the New ICH Q14 Guideline

    The current effective version of ICH Q14-Analytical Procedure Development was adopted on 1 November 2023. Development of analytical procedures under the new ICH Q14 guideline poses significant challenges yet also opportunities for the pharmaceutical industry. From analytical target profiles (ATP) to method lifecycle management, the guideline encourages a structured, risk-based approach that integrates Quality by Design (QbD) principles and analytical advancements into method development activities. Addressing these challenges effectively ensures robust, reliable, and compliant analytical procedures essential for drug development, regulatory approval, and global commercialization. This paper explores the critical aspects of method development and validation under the enhanced approach outlined in the Q14 guideline, emphasizing the key principles and expectations while highlighting strategies to navigate these complexities, optimize efficiency, and enhance pharmaceutical product quality and patient safety. read more