I am delighted to share this success story. We’ve recently achieved a milestone with one of our valued clients—the approval of both major products in a European Union (EU) member state!
This achievement is a true testament to the unwavering dedication and sheer hard work exhibited by our exceptional team. It’s worth noting that this accomplishment comes in the face of unique challenges posed by the product’s characteristics and the stringent evaluation standards set by the regulatory authority of that specific EU member state.
Supra-bioavailable products, as many of you know, often encounter formidable challenges in the intricate web of EU regulatory landscape. However, through a combination of a well-crafted regulatory strategy and the invaluable support from all stakeholders within our client’s organisation, we’ve emerged triumphant in this journey.
This success serves as a resounding testament to our company’s capability to navigate and conquer even the most demanding regulatory hurdles.
While we’re on the subject of great news, we’d like to address a question posed by our client’s legal department:
“Why is the license granted under a different company name, and how we can get this licence back?”
The answer to this inquiry lies in the intricacies of the corporate structure within our client’s group of companies. One of their affiliated companies holds the Marketing Authorisation (MA) for this specific product. As a result, our options for regulatory procedures were somewhat constrained. Initially, we contemplated pursuing the Mutual Recognition Procedure (MRP). However, this path presented inherent regulatory risks, especially in light of reservations held by this health authority regarding supra-bioavailable products. The fear was that opting for the MRP might result in potentially endangering the existing MAs in other markets.
In consideration of these potential risks and to safeguard the client’s current market positions, we made the strategic decision to pursue a national procedure instead. It’s crucial to understand that, since one of the affiliated companies within the group already possessed the MA, we were legally precluded from engaging any other entity to conduct the national procedure within the European Union. Consequently, our only viable option was to collaborate with the local MA holder, leading to the use of a different company name for this purpose.
For your reference, we had a meticulously drafted and signed hard-copy contract in place. One of the clauses in our agreement explicitly states that once the license is granted, it will be transferred to the client group of companies, ensuring a seamless transition.
If you find yourself facing complex regulatory challenges or require a similarly strategic approach, I urge you to look no further. Please book a call with us, and let’s explore how we can assist you in achieving your regulatory goals.
“Accelerated Regulatory Action Call.”
In this concise yet impactful call, we’ll:
🔍 Learn about your business and the regulatory challenge at hand.
🎯 Gain a crystal-clear view of your goals and identify potential regulatory hurdles.
🔧 Develop tailored regulatory solutions to tackle your most pressing challenges.
Best regards,
Aziz