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Compliance partner for adverse event reporting solutions across the drug life cycle.

Our Offerings

  • ICSR Case Processing
  • Aggregate Reporting
  • Literature Surveillance
  • Risk Management System
  • Signal Management & Analysis
  • Medical Information Call Centre
  • Case book-in & Triage
  • Data Entry
  • Narrative Writing
  • Quality Review
  • Medical Review
  • Case Submission
  • Periodic Safety Update Reports (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Periodic Adverse Drug Experience Report (PADER)
  • Canada Annual Summary Report (CASR)
  • Development Safety Update Report (DSUR)
  • ACO reports – Addendum to clinical overview
  • Global literature monitoring
  • Monitoring of the EMA’s Medical Literature Monitoring (MLM) and assessment of safety information
  • Literature monitoring to supports the aggregate reports and signal management process
  • Risk management system development
  • Identification of safety concerns
  • Development and Implementation of risk minimization measures
  • Assessment of risk minimization measures
  • Preparation of RMP update(s) based on change in safety profile of product
  • Literature review
  • Signal detection
  • Signal validation
  • Signal confirmation
  • Signal analysis and prioritization
  • Signal assessment
  • Recommendation for action
  • Medical Inquiry
  • Product quality complaints
  • Adverse event reporting
  • Query management
  • Case follow up

Our Holistic Approch

  • PV System setup & Integration
  • Expedited & Periodic Safety Reporting
  • Safety Surveillance & Risk management activities
  • Setting up and hosting of safety database and management
  • Legacy Data Migration
  • Safety data exchange agreements (Co-licensing, Third party Manufacturer/Distributor, Piggy back ..etc)
  • Support with third parties and channel Partners
  • Pharmacovigilance consulting involving standard operating procedure (SOP) development, quality systems and strategic consulting
  • End to end ICSR case processing including electronic transmission as applicable
  • Dedicated clinical trials team with experience processing cases from early dose determination studies to advance phase 3 clinical trials
  • Integrated PV and Medical information (MI) response centres
  • Medical review case assessment
  • Global literature monitoring
  • Aggregate report preparation and compilation (PSURs, PBRERs, PADERs, CASRs, DSURs etc)
  • End-to-end signal management activities
  • Routine risk monitoring activities
  • Preparation and review of risk management plan, implementation and strategy including additional risk minimization measures, risk communication and effectiveness assessment
  • MAH oversight and support including training, SME review and gap analysis of Risk Management Measures

Advantages

  • Experience in managing end-to-end pharmacovigilance services and understanding the challenges faced by small and medium-sized pharmaceutical companies

  • Experienced team of subject matter experts (SMEs) and Physicians with extensive therapeutic area expertise and strong medical knowledge

  • Wide-ranging experience with multiple regulatory regions

  • Robust planning and processes in place to ensure smooth project transitions

  • Strong expertise in handling ever-changing regulatory requirements

  • Audit ready quality processes, Anytime Inspection Readiness

  • Highly adaptable with proven collaboration across the functional areas

  • Risk mitigation strategies with strong business continuity plan

ADVITY RESEARCH PRIVATE LIMITED

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© 2023 Advity Research, All Rights Reserved.