PV audits
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
