We are a progressive Regulatory Affairs and Drug Development Consultancy supporting the global pharmaceutical industry to achieve product development and regulatory approval in Europe.

Founded in 2007, Sirius Regulatory Consulting is based upon over 30 years experience gained by our Leadership Team within the global pharmaceutical and consulting industries.

Managing Director, Neil Edwards, has over 19 years experience in Regulatory Affairs and drug development gained during leadership positions with premier pharmaceutical and consultancy organisations. Previous positions include European Regulatory Affairs Manager, Bayer Pharma Europe, Director Drug Development Consulting, PAREXEL International, Director Regulatory Affairs, ALTANA Pharma (Nycomed) AG.

Business Development Director, Karin Edwards, qualified as a Pharmacist and has over 14 years experience in pharmaceutical and business development consulting industries. Previous positions include Information Services Manager, Bayer UK, Marketing Information Scientist, Bayer UK, Business Development Manager In-Licensing and Acquisitions, Pharma Ventures Ltd.

As required, we establish bespoke teams with the optimal composition and expertise to achieve client objectives. Teams are built around our extensive network of associate consultants, including subject matter experts, ex-EU regulators and operational personnel. We offer both depth and breadth of regulatory and drug development expertise. Particular therapeutic areas of expertise include oncology, respiratory diseases, cardiovascular, metabolic/ gastro-intestinal diseases, pain and anti-infectives. We also have experience with biological/ biotechnology products and with OTC drugs, including OTC switch or legal reclassification applications.

Please take some time to visit our website to find out more about how we are working with our clients to bring pharmaceutical products to market in Europe.