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DCP Regulatory Strategy for an EU Registration

UK Pharmaceutical company
Est: 2000 Size: 10 - 50

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Project: Empowering a small pharmaceutical company to achieve big results through regulatory strategy, targeted advice, and in-depth research.
Summary: DCP, EU market authorization, SmPC, Medical literature search, CMS, RMS, therapeutic indications, APIs Suppliers, CMS, DC.

The client had no prior experience in EU submissions and how to acquire marketing authorization (MA) in multiple member states. Needing guidance, research, and a regulatory strategy, Arriello created a Decentralized Procedure (DCP) regulatory strategy, and provided support for everything from analyzing medical literature research to giving advice on selecting the right API vendors.

Challenges

With no experience in EU submissions, regulatory processes and which countries they wanted to target the firm needed the full range of Arriello’s regulatory expertise. From direction on how to conduct their bioequivalence studies to advice on which therapeutic indications were right for each country, this UK firm relied on Arriello’s expertise to comprehensively meet its informational and strategic needs.

Additionally, our client also requested help finding active product ingredient (API) suppliers within the EU. Arriello needed to source the most cost-effective vendors—with no sacrifice in quality—so our client could purchase APIs for their drug.

Solution

Arriello crafted a DCP regulatory strategy, with the reccomendation that our client’s reference member state (RMS), was the Netherlands. This choice would be supportive and efficient thanks to the country’s experienced personnel, good communication and respect for timelines. Through research we knew the Dutch Medicines Evaluation Board had already approved a drug containing the same APIs as our client’s drug, and had assessed similar dossiers to our client’s.

For our client’s Concerned Member States (CMS), our DCP strategy targeted Spain, Belgium, and Poland. The Arriello team knew that the composition of our client’s drug was similar to products already approved in these countries. We provided further safety advice, researching scientific articles and analyzing internal Summary of Product Characteristics (SmPC) documents, and hand-selected three GMP-certified companies who could supply the APIs ingredients required locally.

Faster. Better. Smarter.

Our DCP regulatory strategy allowed our client to apply to the EU countries where a faster MA approval was most likely.

Selecting the right countries through good regulatory intelligence created a much better experience, characterized by good communication and collaboration. And we went the extra mile researching local API suppliers.

Finally, we chose the smartest route for success. Instead of wasting effort learning EU regulatory intricacies by trial and error, our client tapped into our team’s combined expertise—charting the most efficient path toward its long-term goals.

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