Uncover Competitor Advantage with Regulatory Affairs

Buckle up because I’ve got a riveting story about gaining a competitive edge that’s hotter than a summer blockbuster!

Our client, a commercial director facing a slump in their major products, decided it was time to play detective. Lo and behold, they discovered that a rival company was enjoying an extra indication that they didn’t have. Cue the dramatic music.

Why, you ask? The competitor’s product had the flexibility to be diluted for a specific indication, while our client’s posology didn’t allow such manoeuvring. But here’s the twist – hospitals were already in the habit of diluting this product for that very indication.

So, why did our client miss the boat on this additional indication? Turns out, their regulatory and medical affairs teams were cautious, blissfully unaware of the hospital’s daily dos and don’ts. Hospitals, in their wisdom, found it convenient to have one product that could serve both concentrated and diluted purposes, rather than cluttering up their inventory with two separate options.

Not surprisingly, our commercial director friend was not doing the happy dance with their internal stakeholders. Frustrated and feeling a bit like Sherlock Holmes, they reached out to us.

Cut to us filing for that additional indication, armed with a comprehensive package that would make any regulatory aficionado proud. The result? A game-changer for our client.

The moral of the story? Always question the status quo. I’m not saying the default position is always wrong, but without a healthy challenge, we risk missing golden opportunities. Think about the patients who could benefit from your life-improving and life-saving medicines.

Here at Assure Regulatory, we thrive on challenging ourselves in our dynamic team. So, if you find yourself in a situation where time is tight and challenges are aplenty, don’t hesitate to reach out. Booking a call with us is the first step to turning challenges into victories.

In this short but powerful session, We will

  • Rapid Assessment: Get to know you, your business, and the background of the current biggest regulatory challenge you are facing.
  • Crystal-Clear vision: Get a crystal-clear vision of what outcome you are looking for, and identify obvious and completely not obvious regulatory traps in the way of your outcome.
  • Customised Strategies: Create bespoke regulatory solutions for your biggest regulatory challenge at the moment.
  • Q&A Session: Get answers to your burning questions and gain clarity on regulatory challenges that have been holding you back.

Book a time that works best for you and make sure you block out at least 45 mins as we’re going to dive really deep into your current biggest regulatory challenge and its solution.

In this one-to-one private and completely confidential Accelerated Regulatory Action Call, we will work with you and resolve your biggest regulatory challenge.

“Accelerated Regulatory Action Call.”

Or simply reply to this email with the subject ‘Book Accelerated Regulatory Action Call,’ and we’ll get our team members on the case. We’ll make sure it’s all arranged at a time that’s convenient for you.

Looking forward to speaking with you and finding Rapid Regulatory Solutions.

If it feels like we’re a good match for each other and we can help you get long-term consistent results, then we’ll let you know how we can help you further.

Best regards,

Aziz