Ah, politicians and their brilliant ideas, or should I say, “brilliant” ideas! Take, for example, our dear friend Rishi Sunak, who decided to play the labelling game with medicines, slapping a ‘UK only’ sticker on them. What could possibly go wrong, right? Now, at first glance, it might seem as simple as pie, but let …
Labelling Laughs and Medicinal Mishaps: The Rishi Sunak Saga Read More »
I hope this message finds you in good spirits, perhaps even binge-watching Netflix series like “Get Gotti.” As I immersed myself in the captivating story of the FBI’s relentless pursuit of notorious mob boss John Gotti, it struck me that even in the world of law enforcement and regulation, speed and agility can be game-changers. …
Fast and Furious Regulatory Affairs: Going from FBI to OCTF Speed! Read More »
I’ve got a story for you, and it’s a cultural rollercoaster from the UK to France, with a little side trip into the magical world of project management. So, picture this: I’ve got two clients, and they couldn’t be more different if they tried. One’s sipping tea and the other’s savouring fine grape Juice, and …
Story of two clients: UK Speed vs. French Finesse! Read More »
You’re probably knee-deep in the exhilarating world of budgeting for 2024. It’s that thrilling time of year when you shuffle numbers and wrestle spreadsheets like a budgetary ninja! Now, let’s talk about the budgeting norm. Most of my regulatory colleagues, bless their cautious hearts, tend to play it safe. They meticulously align their cost centres …
Let me regale you with the hilarious tale of my recent business trip. Picture this: I’m at the airport, determined to ace the security check. I’ve got my laptop, bag, mobile, airpods, wristwatch, cabin bag, jacket, coat, belt, and even some crumpled papers jammed into my pocket, like a one-person jigsaw puzzle. I’m thinking, “I’ve …
Avoiding the ‘Shoe Beeping’ Moments in Regulatory Affairs!” Read More »
We’ve all heard the age-old adage, “A stitch in time saves nine.” In the world of regulatory affairs, this saying couldn’t be truer. When it comes to ensuring your business stays on the right side of the regulations, a proactive approach is worth its weight in gold. Here are a few reasons why we’re the …
In the quirky world of reality TV, a show called “Married at First Sight” took the nation by storm. This wacky concept involved total strangers tying the knot on their first meeting. Some called it daring, some called it absurd, but everyone tuned in for the drama. In one memorable episode, they paired up a …
Regulatory Affairs: Where Compliance Meets ‘Married at First Sight Read More »
Well, let me tell you, we had a rather comical situation at home the other day. My wife, bless her heart, decided it was time to change the locks on our new house. You see, she was convinced that we had no idea who might still have keys to our humble abode from the previous …
Hold onto your hats because we’ve got a story to tell! Our client’s quality department went on a wild adventure through compliance land, comparing their QC specs and analytical methods to what’s written in the license. Buckle up, because they found more twists and turns than a rollercoaster. Our client’s Quality Director had batches to …
Regarding the Windsor Framework’s Packaging and Labelling Requirements, as of January 1st, 2025, all PLUK licensed medicines must bear the ‘UK only’ label on their packaging. Recently, I had the privilege of attending a client meeting with their stakeholders. While I appreciate their diligent focus on implementing this change to comply with regulations and expedite …
Navigating the Windsor Framework’s ‘UK Only’ Label Read More »
