QARA CONSULTANCY LTD

QARA is a premier quality and regulatory consultancy providing tailored, risk-proportionate advice and support to meet your specific needs. With a deep-seated passion for problem-solving and a commitment to excellence, we leverage over 15 years of expertise in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Our firm provides risk-proportionate advice and support to life-science organizations, catering to small start-ups, international corporations, and public sector entities alike. Our services are designed to be flexible, engaging on a temporary, ad-hoc, or retainer basis to meet diverse client needs. Explore further the services we can provide to your organization. Quality Assurance ● QMS: development, assessment, change management, eQMS ● SOP Universe: process mapping, document writing, regulatory compliance review ● Training Universe: strategy, program, sessions & materials ● Deviation Management: incl. Serious Breaches & trend analysis ● Audit & Inspection: internal audit strategy, scheduling & performance, external audit/inspection preparation, hosting, responses Regulatory Affairs ● Submission Advice & Planning: road-mapping, strategization, scheduling ● Technical Writing: documentation development, regulatory compliance review ● Ethical & Regulatory Approvals: collating dossiers, performing submissions, handling queries General Quality Consultancy ● Risk Management: risk evaluation & mitigation, risk-based monitoring strategies, change management risk assessment ● DCTs: strategization, regulatory compliance assessment ● Vendor Management: selection & qualification, performance monitoring, QTA negotiation