Ensuring Patient Safety Through Effective Pharmacovigilance
What We Offer

Pharmacovigilance Services

Comprehensive, compliant, and science-driven drug safety services for pharma, biotech, and healthcare organizations worldwide.

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7+

Services Offered

10+

Regulatory Frameworks

100%

Client Satisfaction

20+

Countries Covered

Our Expertise

Our Core Services

End-to-end pharmacovigilance support designed to meet the highest global regulatory standards.

Individual Case Safety Reports (ICSR)

Comprehensive end-to-end ICSR processing services ensuring accurate, timely, and compliant adverse event reporting.

  • Case intake and triage
  • Medical coding (MedDRA)
  • Clinical narrative writing
  • Causality assessment
  • Regulatory submission (expedited & periodic)
  • Follow-up queries management

Signal Detection & Management

Proactive identification and evaluation of safety signals to support informed benefit-risk decision making.

  • Quantitative signal detection
  • Signal validation and evaluation
  • Benefit-risk assessment
  • Signal management tracking
  • Regulatory authority communication
  • Risk minimization strategy

Aggregate Report Writing

Preparation of comprehensive periodic safety reports aligned with global regulatory requirements.

  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • Development Safety Update Report (DSUR)
  • Annual Safety Reports
  • Clinical Study Reports (safety section)
  • Risk-benefit summaries

Literature Monitoring

Systematic global medical literature screening and review to capture relevant drug safety information.

  • Weekly/monthly literature searches
  • Relevant article identification
  • Individual case extraction
  • Line listing preparation
  • Signal assessment from literature
  • Database screening (PubMed, Embase, WHO VigiBase)

Medical Review

Expert clinical evaluation and medical assessment by qualified healthcare professionals.

  • Clinical evaluation of adverse events
  • Causality assessment
  • Medical coding review
  • Aggregate data medical review
  • Signal clinical assessment
  • Medical writing support

Risk Management Plans (RMP)

Comprehensive risk management planning with effective minimization and mitigation strategies.

  • Safety specification development
  • Pharmacovigilance plan
  • Risk minimization measures
  • Risk communication
  • Effectiveness evaluation
  • REMS program support

Regulatory Compliance Support

Comprehensive regulatory support ensuring full compliance with national and international pharmacovigilance requirements.

  • CDSCO/PvPI compliance
  • EMA & WHO guidelines adherence
  • FDA pharmacovigilance support
  • PV system audits
  • SOP development & review
  • Regulatory training

Need a Customised PV Solution?

Our experts work with you to build a pharmacovigilance programme tailored to your product and regulatory requirements.

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