2richards, Inc

2Richards has extensive experience in the Clinical Research space and has assisted many organizations, from small to large, in the following GCP areas: • preparation and management of regulatory inspections, • deployment and continuous improvement of risk-based quality management systems, • advising on complex compliance questions, • retained consultancy services and interim QA management roles, • delivery of GCP and inspection-related training We work with commercial and nonprofit biopharmaceutical organizations including small starts-ups, medium-sized organizations poised for commercialization, and biopharmaceutical organizations with large portfolios. We are familiar with multiple business models such as Sponsor managed programs, programs and studies outsourced to single or multiple CROs, and complex cross-cultural business partner relationships. 2Richards have experience in trials conducted globally with NCEs, small molecules, biologicals, gene therapy and drug-device combination therapy. We use extensive industry experience to provide practical, risk-based approaches to managing compliance with GCP regulations, focusing on patient safety and data integrity to ensure that resources are applied to what matters most. The application of this pragmatic approach has benefited over 70 organizations to date. Contact us today to see how we can help you prepare for an inspection or advise on building your QMS!