WHO WE ARE QRC Consultants Ltd is a team of experienced QA, regulatory and clinical research professionals, dedicated to providing high quality, practical, responsive and cost effective services to support pharmaceutical companies primarily with early clinical development. The team offers technical expertise with particular strengths including: • Robust knowledge and understanding of the regulatory environment governing clinical trials globally, in particular in the EU and US • Direct experience of regulatory approval, clinical trial management, oversight and audit of early phase clinical trials with biological and advanced therapies. WHAT WE DO QA AND REGULATORY COMPLIANCE All aspects of Quality Systems Management to support all phases of clinical development programmes: • Set up and maintenance of Quality Management Systems • SOP writing • CRO systems audits (global) • Clinical trial audit plans • Preparation for agency inspections. REGULATORY AFFAIRS Support for early phase clinical development programmes: • Product development consultancy • Preparation and review of technical documents • EU Legal Representative services • SME services • Bespoke training in regulatory procedures. CLINICAL TRIAL SUPPORT Support for early phase clinical trials: • Clinical project management • Essential document writing and review • Feasibility studies • Monitoring of early phase clinical trials. Set up and maintenance of eTMFs • Bespoke training in GCP & the clinical trial regulatory environment.