We provide consulting services concerning Current Good Manufacturing Practice (CGMP) in the following areas:
Assessing the adequacy of GMP compliance on clinic material manufacturing in different clinical phases;
Evaluating quality management system and system-based CGMP compliance, including but not limited to:
Providing auditing and gap analysis services for API, OSD, sterile and biotech product manufacturing facilities, including laboratory data integrity evaluation;
Consulting in preparation for FDA CGMP inspections on all manufacturing sites, including biotech product manufacturing facilities;
Providing post-inspection response and CAPA implementation to address any deficiencies, etc.;
Providing blue-print or facility design review to ensure manufacturing facility to be built meeting CGMP requirements.