Dlrc Regulatory Consultancy

The pathway to market is complex, but DLRC can simplify your journey. Operating from our UK, Germany, and US offices with over 1,000 years of combined experience, we collaborate with diverse clients, from top-five pharma companies to SMEs and start-ups. We develop and execute innovative phase-appropriate regulatory strategies to provide comprehensive support from very early in a product's lifecycle to post-licensing activities for medicinal products and medical devices. Our team comprises consultant experts in non-clinical, CMC, clinical, and MedTech fields from pharmaceutical, medical device, and regulatory agency backgrounds. With a wealth of knowledge and experience, we have proudly served over 130 companies of all sizes and backgrounds in various regulatory jurisdictions. Our service offering includes: Strategy • Global strategic advice • Regulatory route to clinic/market • Gap analysis & due diligence • EU CTR: Implementation & transition planning • Health authority engagement & negotiations • Expedited pathways • Paediatric development Operations • Procedural management: Global regulatory agencies • Clinical trial applications • Marketing authorisation • Medical and scientific writing • Regulatory operations and publishing • Regulatory lifecycle management Representation • US agent • Authorised representative medical devices • Legal representative under EU CTR • SME / ODD / MAH holder Our unwavering commitment to excellence has earned numerous accolades and industry recognition, solidifying our reputation as a trusted name in the life science industry. These include King’s Award for Enterprise in International Trade, TOPRA Awards for Regulatory Excellence, ISO 9001 Accreditation, Investors in People Silver Award, Cyber Essentials accreditation, and Queen’s Award for Enterprise in International Trade. Speak to us today to find out how our award-winning team can maximise the potential of your company and products.