PHARMACOVIGILANCE
A comprehensive pharmacovigilance service is provided.
SOP Management
- Crafting, implementing, and auditing SOPs across all areas of PV operations regulated by competent authorities
- Crafting, implementing, and auditing SOPs across all areas of PV operations regulated by competent authorities
ICSR Management
- Continuous adverse event management
- Around-the-clock ICSR reporting services
- Ensuring compliance with regulatory timelines.
Aggregate Report Writing
- Creation and submission of territory-specific periodic reports.
- Risk management master plan.
- Risk assessment documents.
- Clinical safety update reports.
- PSUR (periodic safety update reports) country-specific QPPV Services.
- Qualified Person Responsible for Pharmacovigilance (QPPV) services tailored to the requirements of the client .
- Availability varying from Ad-hoc to 24/7.
- Deputy/local QPPV, and administrative support.
- 24/7 contact point for competent authorities
Literature Surveillance
- Extensive global adverse event literature screening.
- Periodic surveillance of relevant publications.
- Worldwide literature search to detect potential ADR.
- Local journal literature search as per regulation requirement
Signal Management
- Tailored approach as per client requirements.
- A systematic end-to-end solution for signal detection, validation, prioritization, assessment, recommendation for action, and the exchange of information.
Risk Management Plan
- Strategic advice and analysis on risk management activities.
- Assessment and identification of potential risks associated with a product.
- Helping in the development of risk minimization plans.
Pharmacovigilance System Master File
- Prepare and submit the PSMF to the relevant authorities.
- Adhering to regulatory guidelines
- Regular updates and revisions to the PSMF are conducted and reviewed by the QPPV
Audits and CAPA Management
- Ensuring the effective implementation of PV activities by conducting audits.
- Mock audits and inspections at client headquarters, distributors, and relevant sites.
- Identify shortcomings during audits and provides management plans
- Advising on resolutions to harmonize PV systems
