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Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, in particular focusing on product development.
From early stages, we help our clients process the regulatory activities that take a concept from development to product commercialisation. We work at the forefront of the most advanced product types including RNA and DNA technologies and
gene therapy products.
By supporting clinical trial regulatory activities globally, liaising with EMA, EU and national agencies as well as securing SME status for our non-EU clients we have become the EU Regulatory Department of choice for SMEs. Our expert knowledge of EU procedure ensures your success through ATMP Classifications, Orphan Designations, Scientific and Protocol Advice and applications for PIP and PRIME.
‘Perfect strategy in the right order, I love working with you all!VP RA of US based SME company specializing in ultra-orphan products
We received our Day 74 letter and there were many CMC issues raised – as anticipated. It appears that the issues that you have raised correspond to these deficienciesVP RA US based speciality pharmaceutical company