Our Services
CANDOR Vigilance offers PV, PV Quality Assurance, auditing, and training services to clients in the Asia Pacific, Australiasia, and the U.S. (west coast) regions.
1
Pharmacovigilance Audits
-
System/Process
-
Affiliates
-
External Service Provider
-
Licensing Partner
-
Pre-Inspection assessment
Each audit typically includes planning, preparation, and reporting according to the client's requirements and procedures. If required, CAPA management and/or follow-up activities such as CAPA review, approval, and follow-up to completion may be arranged.
2
Risk Assessments
-
Risk Assessment of all audit entity types for in the PV audit universe
-
Documentation of the Risk Assessment Strategy
-
Development of the Annual Audit Schedule / Audit Plan
-
Risk Assessment Tool development
3
Inspection support
Anteroom support - various roles, including:
-
Anteroom lead
-
Inspection Request Tracking
-
QA reviewer, QC of inspection responses
-
Scribe during interview sessions
With experience in remote, onsite, and hybrid settings.
4
Training
-
Basic PV and refresher training
-
Basic audit training
-
PV audit practical training
-
Audit and Inspection readiness training
The scope of training and requirements will be discussed and tailored to the client's needs. Training may include workshops, competency assessment, and documentation as required.
5
Pharmacovigilance support
Open to a range of projects
Let's Work Together
Please get in touch, we look forward to hearing from you.