Tell us about your product, market, and timeline — our specialists will design a testing programme that fits.
Our scientific team will help you identify the right tests, methods, and accreditations for your product or sample.
Auriga creates and manages your PvMF from scratch, ensuring it meets IPC PV Guidance V2.0, CDSCO requirements and GVP Module II at all times.
The Pharmacovigilance Master File (PvMF) — also referred to as the Pharmacovigilance System Master File (PSMF) in the European context — is a detailed description of the pharmacovigilance system used by a Marketing Authorization Holder. It documents the entire structure of the PV system, including personnel, processes, IT systems, contracted activities, and quality management arrangements.
In India, the IPC PV Guidance Document Version 2.0 requires every MAH to prepare, maintain, and make the PvMF available for CDSCO inspection at any time. In Europe, the PSMF is mandated by GVP Module II and the EU pharmacovigilance legislation.
CDSCO Requirement: The PvMF must identify the Qualified Person Responsible for Pharmacovigilance (PVOIC), describe the organisational structure, list all marketed products, and document the quality system procedures. Absence of a current PvMF during inspection constitutes a critical deficiency.
What We Manage
Appointment, qualifications and defined responsibilities of the Pharmacovigilance Officer in Charge — as required by CDSCO.
Documented reporting lines for PV activities — internal team, contracted CRO (Auriga), and interfaces with other departments.
Complete list of all licensed products with indication, dosage form, approval dates and safety reference document references.
Inventory of all current PV SOPs with version numbers, effective dates and links in the Document Management System.
Description of the PV safety database (Auriga Safety System), including audit trail, access controls and validation status.
Records of PV training completed by all relevant personnel — linked to DMS-controlled training materials.
Description of PV activities delegated to Auriga Research, with reference to the SLA/SDEA.
Record of internal PV audits, findings and CAPAs, and any regulatory inspection outcomes.
Contact our PV team for a free consultation on PvMF setup and maintenance.
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