GLP and GMP Compliance
Aptiv Solutions understands that compliance with applicable regulations and guidance throughout the drug development process is essential to achieve pharmaceutical development goals. Our early phase compliance experts work side-by-side with the technical experts in preclinical, CMC and clinical development to ensure appropriate application of key elements of GLP and GMP along the development pathway. Our compliance support approach is tailored to the needs of each client and varies from development of a self-contained, project-specific Project Quality Plan to providing specific quality services such as supplier qualification and auditing as specified in a Technical (Quality) Agreement agreed with a client.
Our compliance experts provide proactive services which include supplier evaluation, risk assessment of process and system change strategies, development of quality systems, site readiness prior to regulatory inspections, and co-development of Pre-Approval Inspection (PAI) readiness strategies with Preclinical and CMC team members. They are also ready to provide immediate and emergency services to assist clients with development of corrective actions in response to deficiencies identified by regulatory agencies. This service includes assistance with resolution of 483 observations and Warning Letter citations issued by the US FDA