idea

Innovative regulatory affairs strategies for innovative products – EU/UK legal representative services

IDEA Regulatory is devoted to supporting pharmaceutical, biotechnology and medical device companies when accessing European markets. With offices in London, Dublin and Munich, IDEA Regulatory is a resource available to companies to assist them in understanding and accessing the regulatory submission paths in the EU and the UK, and accelerate assessments, especially for orphan indications, an area in which the company is specialised. The process of designating a product as orphan, establishing the necessary requirements to start the regulatory path and preparing clinical trials and document submission is an integral part of IDEA Regulatory. Furthermore, IDEA Regulatory can act as representative of a company in Europe and the UK. IDEA Regulatory offers professional advice and support for any questions a company may have regarding EMA and MHRA registration procedures, with partners in the US for any FDA matters.

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