Pharmacovigilance & Safety

Strategy & Consulting Services

Signal  Detection

  • Gap analysis
  • Safety strategy for new markets/ new products
  • Setting up safety systems
  • Safety audits
  • Inspection preparation
  • Support for remediation activities


  • Tracking and Identification of Safety Signals
  • Periodic & ad-hoc review of safety data-clinical & post marketing
  • Medical Review & analysis of signals
  • Risk factor identification
  • Signal Identification- PBRER, DSUR, PSUR,PADER, BRE, IND, RMP, REMA, Label Updates
  • Literature Review & assessment

Safety Content Services

Safety Operations Management

  • ICSR – Spontaneous/Literature/Clinical Trials
    • Data entry/Case processing
    • Narrative writing
    • Causality assessment
    • Quality check
  • Aggregate Reports
    • PBRERs/PADERs/DSURs
    • Quality check
    • Publishing
  • ICSR
    • Setting up operations
    • Receipt, triage and case allotment
    • Follow-ups &  case closures
    • Submission to HA
  • Aggregate Reports
    • Creation/Maintenance of timetable Resource allocation

Safety Information Management

Risk  Management

  • Process automation
  • Validation
  • Transfer of data
  • Compliance
  • Audits
  • Risk Assessment
  • RMP - Drafting / Coordination of review with stakeholders / Quality Check / Publishing
  • REMS - Creation / Execution / Compliance & Audits

Technology Services

  • Safety Database creation
  • System Validation
  • Data migration
Global Regulatory

Strategy & Consulting Services

Regulatory Operations

  • Business Strategy & Consulting
  • Process Centralization
  • Process Standardization
  • Product Portfolio Management
  • GMP Audits
  • Component & Submission Publishing (Paper, eCTD, NeeS)
  • Regulatory Dossier Life Cycle Management
  • Regulatory Document Management
  • Records Management

Regulatory Affairs

Global Labeling & Artwork

  • CMC Support & Change Control Management
  • Gap Analysis, IND, ANDA, MAA, and Post Approval Changes
  • Variations Dossier Preparation & HA Responses
  • DMF, CEP, Annual Updates & Renewals
  • Core Data Sheet (CDS) / Local Product Labels – Authoring, Distribution &  Tracking
  • CDS Content & Change Management
  • Clinical & Non-Clinical Overviews
  • Authoring, SmPC & PIL
  • Artwork & Pack Management

Regulatory Information Management

Health Authority Mandates

  • Product Registrations
  • Quality Data
  • Submission Guidelines
  • Product Classifications
  • FDA Compliance
  • EU – XEVMPD, IDMP & PSMF Compliance
  • EU & FDA – ICH, GMP & eCTD

Regulatory Intelligence

  • Primary & Secondary Regulatory Intelligence
  • New Market & Region Specific Strategy
  • Business Analytics
  • Customized Regulatory Reports
Regulatory Submission Publishing & SPL

SPL data conversion for registration, listing and labeling, we accept raw information in the form of word document and final output is generated which is compliant to current guidelines published by US FDA.