Allow me to transport you into a story of real-life triumph in the world of regulatory affairs pharmaceutical regulation. It’s a story that highlights the difference between a seemingly insurmountable regulatory roadblock and a swift, effective solution.
Our protagonist, a valued client, recently found themselves in a predicament. They had switched their API supplier for one of their key products, a decision that should have ushered in a new era of efficiency and quality. However, this change brought an unexpected twist—the new API material yielded Out of Specification (OOS) results.
As you can imagine, this was not the scenario they had envisioned. The hours of hard work that went into the transition amounted to naught. The batches associated with the new API supplier were effectively on hold, and their commercial team was in desperate need of a rapid resolution.
Turning to their in-house regulatory affairs team, our client hoped for a solution that wouldn’t entail a protracted waiting period of 3-6 months. This is where the plot thickens.
Fortunately, our client had a director who was acquainted with my claim—a claim that our regulatory solutions surpass those of other service providers, even their internal regulatory team.
After a close examination of their data, it became evident that they had been testing two different parameters, with the parameter responsible for the OOS results being, well, insignificant. It posed no threat to the product’s safety, efficacy, or quality. The question arose as to why they had been subjecting themselves to this unnecessary testing in the first place.
Here’s where the narrative takes a compelling turn. I recommended a do-and-tell IA variation as the solution. Our expert team swiftly prepared and submitted the necessary documentation, and the regulatory authority granted its approval.
In this story, it’s a case of “do and tell.” Their Quality Person (QP) released the product without delay. The difference in regulatory approaches became abundantly clear.
In one scenario, the product faced a grueling wait of six months. It required an extensive variation package with ample justification to widen the limits. During this time, the product’s shelf life dwindled, stock levels depleted, competitors encroached on market share, and sales suffered.
In the other scenario, our client successfully navigated the regulatory maze, ensuring their product was back in the market within a mere week. No out-of-stock situation, no loss in market share, and no decline in sales.
The moral of the story? There are myriad ways to approach regulatory challenges. Anyone can opt for the long, expensive, and nonchalant route, but the real challenge lies in finding swift, efficient solutions that prioritise patient and commercial needs.
If you seek the path of quick, efficient, patient-centric, and commercially sensitive regulatory solutions, it’s time for us to have a conversation.
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