QRC Consultants Ltd
QRC Consultants, experienced professionals dedicated to providing high quality, cost-effective support to biopharmaceutical companies in early clinical development. We offer technical expertise with strengths including: understanding of the regulatory environment governing clinical trials globally; regulatory agency meetings and submissions – trial management, and monitoring and audit of trials; and small molecules, biological and advanced therapies. Services include: quality assurance – setup and maintenance of QMS, GCP audits and agency inspection preparation; regulatory affairs – technical document writing, SME and EU legal representative services, and bespoke procedural and GCP training; and clinical trial support – project management and monitoring.