A robust pharmacovigilance system enables continuous monitoring of the safety profile of medicinal products and supports ongoing assessment of their benefit-risk balance throughout the product lifecycle. Our pharmacovigilance services are aligned with applicable provisions of the Drugs & Cosmetics Act and Rules, Schedule M and current CDSCO pharmacovigilance guidance, as applicable to the product and regulatory pathway.
What We Deliver
- Pharmacovigilance System Implementation — Design and implementation of pharmacovigilance systems, including governance, processes, responsibilities and applicable documentation.
- Pharmacovigilance System Master File (PSMF) — Preparation, maintenance and periodic updating of PSMF documentation in accordance with applicable requirements.
- ICSR Processing — Receipt, assessment, data entry, medical review, follow-up, coding and processing of individual case safety reports.
- ADR Monitoring & Reporting — Systematic collection, assessment and reporting of adverse drug reaction information from relevant sources.
- PSUR / PBRER — Preparation, review and submission support for Periodic Safety Update Reports and applicable PBRERs.
- Literature Search & Monitoring — Routine screening of relevant scientific literature for adverse events, safety signals and other reportable information.
- Signal Detection & Evaluation — Identification, assessment and documentation of potential safety signals and emerging risks.
- Risk Management Plans — Preparation and maintenance of risk management documentation and implementation of applicable risk-minimisation measures.
- Pharmacovigilance SOPs & QMS — Development and review of PV SOPs, work instructions, forms, workflows and quality-management documentation.
- PV Audit & Inspection Readiness — Gap assessment, audit support, inspection readiness and remediation assistance for pharmacovigilance systems.
Our Approach
Assess
We assess your existing pharmacovigilance framework, product portfolio and applicable regulatory obligations.
Implement
We establish or strengthen the required PV processes, documentation, responsibilities and reporting workflows.
Monitor & Report
We continuously monitor safety information, process cases and prepare applicable regulatory safety reports.
Maintain & Improve
We support ongoing compliance through periodic reviews, signal monitoring, audits, inspections and system improvements.
Who this is for
Why Choose Vaayath for Pharmacovigilance?
- Regulatory Expertise — PV systems aligned with applicable Indian regulatory requirements and evolving regulatory expectations.
- End-to-End Support — From PV system setup and SOP development to case processing, reporting and ongoing compliance.
- Regulatory & Quality Integration — Integration of pharmacovigilance with regulatory affairs, quality systems and product lifecycle requirements.
- Inspection Readiness — Support for PV audits, inspections, gap assessments and CAPA implementation.