Quality Assurance and Regulatory Affairs
The Quality Assurance (QA) Unit has instituted a robust Quality Management System (QMS) within TRIO. This includes a comprehensive suite of Standard Operating Procedures (SOPs) and Standard Guidelines (SGs) to govern activities, internal and external audits, validation of computerized systems, an electronic Corrective and Preventative Action (CAPA) management system and an effective training program.
The Regulatory Affairs (RA) Unit is experienced in Clinical Trial Application (CTA)/Investigational New Drug (IND) submission and maintenance procedures for many countries. For those countries in which TRIO doesn’t have a local representative but still requires one, TRIO has partnered with companies to carry out the submission activities. TRIO maintains oversight of these partners in the process. The RA Unit conducts ongoing regulatory intelligence and provides regulatory advice and training on country specific clinical trials regulations.