There’s a phrase in EU GMP Volume 4 that was a pleasant surprise the first time I read it. It struck me as a very good idea, and I wondered why other GxPs hadn’t done something similar. From Part 1, Chapter 4: “The various types of documents used should be fully defined in the manufacturer’s […]
Defining Records: A Case for Clear Documentation Practices in GxP Environments Read More »
Compliance is often seen as a cost centre— a regulatory obligation that drains resources; I’d like to redefine it as a strategic enabler of financial resilience and commercial value. Cost Efficiency Through Reduced Disruptions QA-related issues such as downtime, failed inspections, or delayed approvals heavily impact budgets. Between June 2012 and September 2023, the FDA
Compliance as Strategy: Driving Efficiency, Resilience, and Market Advantage Read More »
In the dynamic landscape of the pharmaceutical industry, the Medical Information (MI) function plays a pivotal role in delivering accurate, timely, and compliant information to healthcare professionals (HCPs), patients, and stakeholders. However, ensuring compliance in this area is increasingly complex, with regulatory scrutiny, technological advancements, and rising patient expectations creating significant challenges. This blog post
Congratulations, you’ve made it! After years of R&D, clinical trials, and regulatory submissions, your small biotech has finally secured its first commercial product approval. The hard work is done, right? Not so fast. As you pivot from a development-focused organization to a commercial one, a new and critical function takes center stage: Medical Information. This
Discover strategies to optimize and maintain a Pharmacovigilance QMS in 2025, ensuring global compliance, efficiency, and patient safety across diverse markets. In the ever-evolving landscape of pharmaceutical and biotech industries, a robust Pharmacovigilance Quality Management System (PV QMS) is the cornerstone of patient safety, regulatory compliance, and operational efficiency. As organizations expand into global markets,
In June 2025, the FDA announced the availability of a final guidance document containing questions and answers on conducting remote regulatory assessments (RRAs). Any examination, that is not on site, of the compliance of an agency-regulated establishment, or its records, is an RRA. The background section points out that they may request any records or
FDA Remote Regulatory Assessments (RRAs): Key Takeaways Read More »
Quality Assurance (QA) teams play a critical role in ensuring compliance, maintaining regulatory integrity, and continuously improving organizational performance. However, the very nature of QA highlighting gaps, enforcing standards, and evaluating processes can often lead to friction, both within teams and with other stakeholders. In audit environments especially, these tensions can escalate, affecting team dynamics
Effective Conflict Resolution & Navigating Challenges in QA Teams and Audits Read More »
RiverArk Ltd. is proud to announce that we have been ranked #57 among the 100 Small organisations on the UK’s Best Workplaces for Wellbeing™ list. The Best Workplaces for Wellbeing list focuses on employees’ holistic experiences of wellbeing at work, including their work-life balance, sense of fulfilment, social support, job satisfaction, and financial security, to
RiverArk named one of the UK’s Best Workplaces for Wellbeing™ 2025 Read More »
The pharmaceutical industry is subject to stringent regulations that demand strict adherence to quality standards to ensure the safety and efficacy of medicinal products. The cost of quality (CoQ) plays a crucial role in balancing financial performance with quality assurance. Understanding CoQ enables businesses to enhance efficiency while maintaining compliance with Good Practices (GxP) and
Pharmaceutical Cost of Quality Analysis Read More »
RiverArk is excited to host our first Coffee Morning & Quality Roundtable as part of our commitment to industry collaboration and knowledge-sharing. The event is free of charge. Join us on Friday, March 28, 2025, at The Melting Pot, Edinburgh, UK. As a leading player in quality assurance and regulatory compliance, RiverArk is committed to
Join Us for RiverArk’s Coffee Morning & Quality Roundtable in Edinburgh! Read More »
