END-TO-END PHARMACOVIGILANCE (PV) SERVICES
We provide end-to-End Pharmacovigilance Services, which is the comprehensive suite of activities and solutions that ensure the safety, quality, and compliance of medicinal products across their lifecycle—from development through post-marketing.
Here’s an outline of our services:
Pharmacovigilance System Establishment & Strategic Planning
Pharmacovigilance System Setup
PV System Master File (PSMF): Creation and lifecycle maintenance of the PSMF as per EU and other regional requirements.
SOP Development: Authoring and implementation of Standard Operating Procedures (SOPs), Work Instructions (WIs), and controlled forms to ensure regulatory compliance and operational consistency.
Governance & Oversight: Establishment of pharmacovigilance governance committees and safety boards for continuous oversight.
Quality Policy & Objectives: Definition of PV quality policy aligned with GVP modules and continuous improvement practices.
Regulatory Strategy & QPPV/LPPV Support
Global PV Regulatory Intelligence: Ongoing monitoring and integration of changing global PV regulations (e.g., EU GVP, FDA, PMDA, CDSCO).
QPPV Services: Provision of Qualified Person for Pharmacovigilance in the EU, with 24/7 availability and local oversight.
Local PV Representatives: Deployment of Local Safety Officers (LSOs) or Local Contact Persons for PV in non-EU countries.
Post-Marketing Pharmacovigilance (Marketed Products)
ICSR Management
Case Intake & Triage: Intake from multiple sources (HCPs, consumers, literature, partners) and accurate triage based on seriousness, expectedness, and relatedness.
Data Entry & Coding: Accurate entry into safety database, using MedDRA coding.
Medical Review: Qualified physicians evaluate causality and clinical relevance.
Regulatory Submission: Timely transmission to EudraVigilance, FDA, MHRA, and local HA systems in ICH E2B(R3) format.
Literature Monitoring
Global & Local Literature Screening: Weekly review of indexed and local literature to identify safety signals or ICSRs.
Scientific Literature Assessment: Medical evaluation of published case reports and their classification.
Aggregate Reporting
PSUR/PBRER Creation: Preparation of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) in accordance with ICH E2C(R2).
PADERs: Preparation and submission of Periodic Adverse Drug Experience Reports (FDA requirement).
AddCOs & DSURs: Additional clinical overviews and periodic developmental reports.
Clinical Trial Pharmacovigilance (Pre-Marketing Safety)
Safety Data Management
SAE/SADE Management: Collection, evaluation, narrative writing, medical review, and timely reporting of serious adverse events and device events to authorities and Ethics Committees.
Safety Reconciliation: Reconciliation between safety database and clinical database (e.g., EDC systems).
Safety Planning & Documentation
Safety Management Plans (SMP): Authoring of SMPs outlining roles, timelines, and data flow for each study.
Investigator Brochure (IB): Contribution to safety sections of the IB, with regular updates.
Development Safety Update Reports (DSURs): Preparation and submission of DSURs per ICH E2F guidelines.
Signal Detection & Risk Management
Signal Management
Signal Detection: Data mining and signal detection using tools (e.g., Empirica Signal, VigiBase, OpenVigil).
Signal Assessment: Causality, strength, and frequency evaluation using WHO and EMA methodologies.
Signal Tracking: Maintenance of signal tracking logs and signal detection reports.
Risk Management Plans (RMPs)
Authoring RMPs: Comprehensive development of RMPs per EMA and local regulatory guidance.
RMM Implementation: Support in executing routine and additional risk minimization measures (e.g., educational materials, controlled access programs).
Effectiveness Evaluation: Measurement of RMM implementation outcomes through surveys, audits, or KPIs.
Regulatory Intelligence & Compliance
Global Compliance Monitoring
Local Regulations Monitoring: Tracking country-specific PV requirements in real time.
Submissions & Communication: Timely submission of reports and prompt responses to Health Authority (HA) queries.
Regulatory Inspections & Audit Support
Inspection Readiness: Preparation of inspection-ready documentation and training.
Audit Conduct & Hosting: Internal PV audits, partner/vendor audits, and support during regulatory audits (EMA, MHRA, FDA, etc.).
CAPA Management: Root cause analysis, corrective and preventive action implementation, and tracking.
Training, Quality & Continuous Improvement
Training Programs
GVP Compliance Training: Onboarding and refresher training for PV staff.
Role-Specific Education: Training tailored for cross-functional departments (QA, RA, Sales, etc.).
Client Education: Training modules for MAHs and partners.
Quality Oversight
Internal Audits: Routine auditing of PV processes and documentation.
Deviation & CAPA Handling: Investigation, documentation, and closure of non-conformities.
Metrics & Performance: Ongoing review of KPIs and quality indicators to drive improvements.
Product Quality Complaints (PQCs)
PQC Intake & Assessment: Coordination with Quality teams to assess safety relevance.
PQC-AE Reconciliation: Ensuring complete capture and reporting of linked safety events.