We are a freelance consulting group providing quality assurance services to the pharmaceutical industry. We work with each of our clients to identify the best approach to achieve compliance and a practical path forward. Each organization has a unique vision and culture and there is no "one size fits all" road to compliance. Our services span the full range of quality assurance activities, allowing us to provide expert support to Sponsors, CROs and clinical investigators on a contract basis. • GCP auditing• Supplemental QA staff (director and manager levels)• Trial master file process and system development• Inspection readiness support• Risk assessments and gap analysis• Auditor training• SOP development and writing• Special projects and continuous improvement initiatives