Pharmacovigilance Services

Safety of drug is always the biggest concern of Pharma companies as well as regulatory agencies. Lead by detailed regulations of EU and USA regulatory agencies, other country regulators are also increasing their expectations for compliance to Pharmacovigilance regulation. Increase in requirement for Risk Management Plan, Periodic Safety Update Report (PSUR), Pharmacovigilance Master File, Local QPPV etc are obvious example of this.

Due to lack of well trained and experienced resources, to get compliance and cost effective Pharmacovigilance activities are always challenging for small and midsize pharma companies. We offer solution to these challange by our end to end as well as bespoke service business model. Our stand alone service for Pharmacovigilance Auditing, RMP preparation, PSUR preparation are very well appreciated by our clients

WHY CELUI

  • End to End PV services under one umbrella
  • Presence of cooperative partners in all EU/US and CIS countries who can act as QPPV/ Pharmacovigilance point of contact for our client
  • Flexible and Cost effective business model
  • Standalone activities eg. RMP,PBRER,PSMF etc preparation
  • End to end PV service
  • Back office support for Literature, ICSR processing for global CROs
  • Robust Quality Management System lead by dedicated Quality Assurance team which assures 100 percent compliance in reporting data to regulatory agencies/ client
  • Trained and experienced pharmacy and medical professionals with hands on experience on all leading safety database
  • Proven track record of quality and compliance
  • Transparent process of monthly compliance monitoring which enable client to have complete and effective oversight on PV activities

Services offered by CELUI

  • Qualified Person for Pharmacovigilance (for EU)/ Local Responsible person for Pharmacovigilance (For CIS)
  • Pharmacovigilance System Master File (PSMF)
  • Detailed description of Pharmacovigilance
  • PV Project Management
  • Global Literature Search & Review
  • Medical Inquiry Management
  • Individual Case Safety Report (ICSR) Management
  • EudraVigilance Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Periodic Safety Update Report (PSUR)( or PBRER/PADER) preparation and submission
  • Risk Management Plan preparation review and management
  • Signal Detection & Evaluation
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly Compliance and Status reporting
  • Pharmacovigilance Awareness Training
  • Global Safety Database Management
  • Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners
  • Company Core Safety Information (CCSI) and Company Core Data Sheet (CCDS) preparation and maintenance

PHARMACOVIGILANCE PROCESSES

DATA COLLECTION

  • Collection of cases various sources:
  • Voice, Email, Fax & Letters
  • Scientific Literature from world wide global database
  • Regulatory Authorities
  • Digital Medium ‐ Websites, Social Media
  • Others

CASE PROCESSING

  • Case Triage
  • Data entry, MedDRA and WHO coding
  • Labeling and Causality
  • Narrative writing
  • Quality check

MEDICAL REVIEW

  • Medical Review of Case: Confirm casE seriousness, event expectedness, causality
  • Aggregate report review
  • Analysis of Event of Special Interest
  • Drug: event Trend analysis
  • Literature review support
  • Line listing review
  • SmPC/PIL Preparation/updation

AGGREGATE REPORT WRITING

  • Writing and review of PBRER, PSUR, DSUR,PADER, RMP

SIGNAL DETECTION

  • Signal Management
  • Response to regulatory safety related queries

REGULATORY SUBMISSION

  • Eudravigilance (EU) and Electronic Submission Gateway establishment (USA) and electronic reporting
  • XEVMPD Data entry and management

PROJECT MANAGEMENT

  • Dedicated well trained project manager for all projects
  • Pharmacovigilance Management Plan
  • Safety Data Exchange Agreement

QUALITY MANAGEMENT SYSTEM

  • Pharmacovigilance System Master File
  • Compliance Monitoring
  • Quality Management Plan
  • Routine System and Process Audit