Services
Operational QA Services
We can provide operational QA support managing QA activities at API and Drug Substance CDMOs including: review and approval of protocols, reports, batch records, and other project-specific documentation; QA oversight of CDMO deviations, investigations, CAPA, and OOS; clinical batch release operations, establishment of Quality Agreements.
Development and Implementation of Quality Management Systems
We can assist in the development and implementation of a Quality Management System including development of SOPs and Policies; establish training program; assisting in the hiring and training of QA professionals; develop Quality Agreement templates.
GLP / GMP Auditing Services
We can provide clients with comprehensive audits assessing vendor compliance with US GLP and GMP regulations and guidances. We can also assist in the remediation of audit findings with the vendor.