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.
Frequently Asked Questions
IDEA Regulatory understands the needs of healthcare companies which are not present in the UK or EU and wish to perform clinical research in these territories. IDEA Regulatory has been performing clinical trials as a legal representative in the EU and UK for many years, accompanying products from the early phases to the final market approval.
IDEA Regulatory can support your Orphan Drug designation application, including joint FDA-EMA procedures. This will allow your company to continue clinical development in many countries with common regulatory support.
IDEA Regulatory has been guiding companies with CE mark registration procedures for many years and now – following Brexit – continues to support the neccessary procedures and performance of trials under the new EU legislation.