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PHARMACOVIGILANCE SERVICES

CLINISYD Research Global Solutions Pvt Ltd based in Bangalore, India, offering Pharmacovigilance, Quality Management System and Training services to the Bio and Pharmaceuticals companies. Pharmacovigilance is the requirement for Marketing
Authorization Holders to ensure the benefits risk assessment of the products available in the market and or in clinical trial phase of the product life cycle.
The CLINISYD Research provides professional support in the area of Pharmacovigilance, QMS and training services; offering top quality, ethical services with enthusiasm; enriching professional relationships with global strategic thinking; and as a result, becoming a preferred partner to our clients.

Pharmacovigilance Consulting
  • Safety strategy for new markets/new products and gap analysis
  • Establishment of PV system and SOP/WI writing
  • Establishment of PSMF/PvMF and safety database
  • QPPV/Pv OI Services
  • PV audits, Regulatory queries handling, Inspection readiness, Training
Pharmacovigilance Operational Services
  • ICSR – processing & submission
  • Literature review and assessment
  • Aggregate reports (PSUR/PBRER/DSUR/PADER)
  • Safety Data Exchange Agreement (SDEA)
  • Risk management plan (RMP)
  • Signal detection
  • Medical Information & market complaint handling

Safety Database Services

  • Safety database implementation & maintenance
  • System validation & data migration

Quality Management System & Training

  • Quality Management System establishment w.r.t GMP, GLP, GCP & GVP standards
  • Assistance with ongoing monitoring of processes (internal and CRO/vendor) and deliverables (ICSR, PSUR etc.)
  • Pharmacovigilance system audits of the global function, regional and local offices, business partners, CROs, and third-party vendors
  • To provide the training to responsible PV personnel to understand the procedure and obligations of Pharmacovigilance as per Regulatory Agencies requirements
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