What is Real?
Proven methods. Measurable results.
Real Regulatory is a consultancy firm delivering positive solutions to our client companies since 2002. From the beginning, our philosophy has been committed to professionalism: to provide consistently reliable results, to move fluidly with the ever-changing regulatory landscape, and to always be worthy of the trust our loyal clients place in us.
Specialising in European regulatory affairs, quality systems and compliance for products including medicines, medical devices, and drug device combinations, we are a dedicated regulatory affairs service which supports and advises companies on meeting their regulatory obligations.
We approach every challenge holistically, with teams comprising experienced and dedicated subject-matter experts in regulatory strategy, clinical development strategy, quality assurance, project management, regulatory operations and much more.
For some companies, European regulatory strategy comes as an afterthought. At Real it’s central to everything we do. Our panel of experts produce bespoke strategies for all of our clients, ensuring swift and timely approvals. It is a core competency.
The Real Regulatory team works consistently to the highest quality process standards as attested by our ISO 9001:2015 certified quality system, ensuring our attention to the small details leads to your success.
Our process mapping activities ensure all decisions and required actions on your project are carefully recorded and tracked, providing complete visibility of progress towards your regulatory approval.
With extensive experience in various organisations, from large ethical multinationals to SMEs, our team of experts specialise in supporting innovation for advanced therapy biotechnology products, new chemical entities, through to hybrids of known products.