Real Regulatory | European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance

Keeping it Real since 2002

(Do it right, do it the Real way)

Proven Experts

We are a multi-skilled and diverse team of proven experts in European Regulatory Affairs

Certified Success

Our certified ISO 9001/2015 Quality System ensures consistency of deliverables and project oversight

Unrivalled Support

Strategic & operational support of EU product development programs for small molecule through to advanced therapy medicinal products

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.