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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.

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.

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.​

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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.

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.

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.​

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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.​

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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.

​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.

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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.

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.

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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.

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