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.