Toscano Consulting Group, Inc. (TCG)
TCG helps companies in the global pharmaceutical, biologic and medical device industries develop and execute comprehensive quality systems solutions. They are recognized as Data Integrity experts and have conducted numerous audits and assessment to evaluate quality systems. In addition, TCG has led global remediation activities related to Data Integrity deficiencies to help clients, both domestic and international, address regulatory enforcement actions.
Their background and broad range of experience includes validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances, and current Good Manufacturing Practices (cGMP) training. TCG has provided hundreds of companies with expert counsel on laboratory and manufacturing investigations, Corrective and Preventive Actions (CAPA) development and implementation, training, stability programs and other quality systems. Their team members have served as project leads and expert consultants on compliance initiatives involving corporate 483 responses, warning letters, consent decrees and application integrity policies (AIP).