LeksWell

LeksWell offers full scope of quality management services and quality consulting within biotech and pharmaceutical industry. Our highly qualified consultants can support you in challenging projects helping your organization to meet quality standards and relevant regulatory requirements LeksWell specializes in - Development of Quality Systems (SOP, Working Instruction, Policy, other procedural documents writing), - Auditing (GCP, GMP, GLP, GcLP, GDP, GVP, CSV), - Vendor qualification - Risk management - Consulting in quality management (Clinical quality, manufacturing, distribution, laboratory, pharmacovigilance, computerized systems validation), - GxP training - Staffing solutions. Our consultants are experienced professionals in supporting organizations with health authority inspections on various stages including: pre-inspection activities, hosting, inspection responses and CAPA follow-up where needed.