360CQA offers its clients a tailored GVP auditing service covering one or more areas on a global level which represents an opportunity for our clients to focus their compliance activities where they are most needed. With significant industry, inspection,
and auditing experience, the 360CQA GVP team has sufficient capabilities to ensure our clients receive the highest level of expertise both at the GVP systems and process audit level.
Our
highly experienced, trained, and competent team of GVP auditors has conducted more than 50 audits according to international and China regulations for tens of sponsors.
OUR RANGE OF GVP SERVICES INCLUDES：
PV Management System audit
PV procedures audit, including:
SAE Handling
SAE Assessment
SAE Collection with/without Expedited Regulatory Reporting
Periodic Safety Reporting according to the individual country requirement
Entry of SAE in Safety Database and Narrative Writing
Quality Control & Generation of CIOMS/MedWatch Report
Report SUSARs to Health Authorities
Report SUSARs to Central/Local Ethics Committees
Prepare & Distribute Safety Letters to Investigators, IRBs/EC
Prepare & Distribute SUSAR Line Listings
Generation of Aggregate Safety Report
Submission of Aggregate Safety Report
RA mock inspection:
Staff mock interview
PV quality system assessment
According to the client’s requirements, conduct the whole process mock inspection for selected cases (SAE, SUSAR)
PV for Pharmaceuticals/ Drug safety department’s team building:
Staff （Drug Safety Associate, QA staff ）recruitment
Staff training
Organization structure in the Drug Safety department
Technical support of PV quality system development in Pharmaceuticals