Complete ranges of PV audits undertaken are System Audit, Vendor Audit, Co Marketing Partner Audit
Audit Certificate in any geography
Development of QA system for PV activities, such Master Quality Plan,
Risk based Internal Audit Strategy
Facilitate MAH for Inspection Readiness & assistance in preparing MAH’s responses to Inspection findings
Quality Management System
Technology based Management of Audits, Inspection & CAPAs
Setting up Pharmacovigilance systems
Establishing an Organogram
Job descriptions
Developing SOPs & WI
Identification of Pharmacovigilance methods
Case processing systems
Training of staff
Literature selection & triage
Signal identification and detection techniques
End to end Case processing
Following established guidelines, data from source documents is processed in to a Drug Safety/Pharmacovigilance database. This may involve an initial triage and a subsequent review of the report. Once finalized, the case reports are submitted to the regulatory authorities. The processing of individual case safety reports (ICSRs) originating from various sources:
Post-marketing reports
Clinical trial reports
Medico-legal, Literature reports
Scheduling patients’ visits and ensuring retention till study completion, Keeping the investigator informed and compliant
Training
Customized training on Good Pv Practices, Safety Regulation Updates, etc
Providing customized training material & Corporate Training
Establishing Safety software
Selection of safety database like ARISg & ARGUS
Facilitate installation, validation, dry runs
Support services
Aggregate Report Writing- PSUR, DSUR
Preparation of Risk Management Plans
Conducting PMS studies
ICSR Review & Narrative Writing
Development of SOPs