blog

My month-long internship at RiverArk represented far more than a simple work experience; it marked a pivotal moment in my personal and professional development. Coinciding with my twentieth birthday, this opportunity served as a meaningful transition into both adulthood and the professional world. It felt very symbolic in its own way. I felt as if […]

Being the first person to ever do work experience at RiverArk was a unique and memorable opportunity. Although the placement was virtual and only lasted a week—from March 3rd to 7th, 2025—it gave me deep insight into the values, mission, and day-to-day operations of a community-focused organisation. I felt proud to represent not only myself

In a significant move toward digital transformation, on 02 Jun 2025 the U.S. Food and Drug Administration (FDA) unveiled a new generative AI tool named Elsa, designed to enhance operational efficiency across the agency, including streamlining scientific reviews. FDA Commissioner Marty Makary praised the early and cost-effective rollout, stating, “Today’s rollout of Elsa is ahead

In the digital age, maintaining data integrity is essential, especially in the pharmaceutical industry, where regulatory compliance is critical. The ALCOA+ principles—Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available—offer a framework for data integrity, also applicable to digital systems. Each principle emphasises precise documentation, accurate record-keeping, and secure, accessible storage.   Key Challenges in

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

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

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