Pharmacovigilance Services

The increase in reporting of adverse events (AEs), scrutiny by public health policy makers, product recalls due to concerns over safety and efficacy and litigations against life science companies are now common.

We are specialized in providing drug safety, scientific knowledge-based services to biopharmaceutical, generic pharmaceutical, consumer product, medical device, contract research and healthcare companies – in the areas of safety & risk management and post-approval support services. Our broad range of solutions and services include full case management (incl. case intake, data entry, triaging, MedDRA coding & causality assessment, QC, medical review, submission, etc.), generation of expedited and periodic reports (PSURs, PBRERs, PADERs, etc.), risk management strategies, medical/scientific literature review, analysis and trending of cases (signal detection), and a medical information center that handles medical inquiries/information and product complaints.

A team of highly qualified professionals with their experience ranging from 3 to 7 years are ready to take up any challenges to meet their customer’s requirements. Their expertise ensures that the things are on track.

We can use your systems and processes or ours to provide support to our clients. By adopting market-leading technologies, we ensure reliable and high performance solutions.

ICSR Management

  • Intake and Follow-up
  • Processing
  • Quality Review
  • Medical Assessment
  • Submission

Medical Literature Review

  • Advance Filtering Capabilities
  • Literature Search
  • Duplicates Elimination
  • Central Repository for daily hits of articles

Aggregate Reports


Risk Management Plan

  • Safety Specifications
  • Pharmacovigilance Plan
  • Risk Minimization Measures

Signal Management

  • Report Generation
  • Identification of Signals
  • Clinical Assessment
  • Regulatory Search
  • Validation and Distribution of Signals

PV Compliance Management

  • Periodic Review of PV System
  • Ensuring Compliance of PV Activities using various Tools
  • Monitoring Regulatory Compliance

Quality Management System

  • Standard Operating Procedure and Work Instruction Management
  • Process Review
  • Documents Handling
  • SDEA/PV Agreement Management
  • Pharmacovigilance Training
  • Audit and Inspection
  • CAPA Management
  • Regulatory Query Handling