We are witnessing a historic moment in American politics. Recently, President Joe Biden announced his decision to end his presidential race for the 2024 election, passing the torch to Vice President Kamala Harris. This decision marks a significant shift in the political landscape, as Harris steps up as the Democratic candidate to challenge Donald Trump …
Embrace Change for Success: Let’s Take the First Step Together Read More »
Do you follow England in Euro Championship 2024? If so, it’s been a rollercoaster ride: Another heartbreak. 58 years and counting. Fans claiming England played negative football. Pundits arguing that England has the best squad, but not the best team. Questions swirling around the captain Harry Kane and manager Gareth Southgate’s future. It’s easy to …
We in regulatory affairs are passionate about systems and publishing tools, and regulatory authorities are no different. However, when these tools or the IT systems supporting them go down, everything comes to a standstill. When the business demands an urgent submission during such downtime, the usual response is, “We can’t.” Recently, one of our clients …
I wanted to share some insights based on my recent interaction with one of our client’s PV colleagues. As a UK-registered pharmacist and regulatory professional, patient safety is my top priority. It’s essential for the Marketing Authorisation Holder (MAH) to meet their legal obligations and ensure their product’s safety in the market. However, I’ve observed …
In the journey of managing teams, whether in corporate roles or my own business, I’ve learned a crucial lesson from one of my mentors: clinical problems cannot be solved with management processes. Reflecting on my past experiences, I always strived to support team members, helping them align with the team’s and business’s goals. I employed …
Clinical problems cannot be solved with management processes Read More »
This past weekend in Luton, England was absolutely electrifying as BBC Radio 1 hosted a sensational three-day music concert. My wife attended the day Coldplay performed, opting to go with her friends instead of taking a “boring” regulatory guy like me. We both had a blast in our own ways, while she was enjoying the …
Regulatory Affairs (RA), a field that truly serves as the heart of the pharmaceutical industry. Imagine RA as the heartbeat of our company. Without marketing authorisations, we can’t sell our products. Without GMP certifications, we can’t manufacture. Without controlled medicines licenses, we can’t provide essential medicines to patients. RA is essential to ensure our supply …
A recent client approached us for assistance in submitting an updated IND application to the FDA. They had switched from using 3 x 2ml ampoules to a 6ml pre-filled syringe for their co-packaged product. While their product development partner excelled in technical studies and development reports, they needed our expertise to ensure regulatory compliance. The …
Have you ever found yourself in a meeting where Regulatory Affairs (RA) and Quality Assurance (QA) colleagues seem to be speaking entirely different languages? It’s a common scenario: RA requires a QP declaration, while QA insists it should be prepared by regulatory and vendor assurance and sent to the QP for signature. Meanwhile, vendor assurance …
In the hustle and bustle of our daily routines, it’s easy to lose sight of why we embarked on this journey in the first place. Yet, at the core of our endeavours lies a sacred purpose – a purpose that transcends mere transactions and touches lives in profound ways. “We get what patients need.” These …
