Enquire Now

Our Commitment to Continuity & Compliance

CMPV Consultancy LLP is committed to ensuring uninterrupted delivery of pharmacovigilance, regulatory, and safety services under all circumstances. Our Business Continuity Plan (BCP) is designed to safeguard client operations, patient safety, data integrity, and regulatory compliance during any disruptive event.

This plan aligns with ICH, WHO, ISO 22301 principles, and applicable global pharmacovigilance regulatory expectations.

Purpose of the Business Continuity Plan

The purpose of CMPV’s Business Continuity Plan is to:

  • Ensure continuity of critical pharmacovigilance activities
  • Minimize disruption to client deliverables
  • Protect patient safety and regulatory timelines
  • Maintain data security and confidentiality
  • Enable rapid recovery from operational disruptions

Scope of the BCP

This plan applies to all CMPV Consultancy LLP operations, including:

  • Individual Case Safety Report (ICSR) processing
  • Signal detection and risk management
  • Aggregate report preparation (PSUR, PBRER, DSUR)
  • Regulatory submissions and safety reporting
  • Medical review and quality oversight
  • Pharmacovigilance audits and inspections
  • Training, documentation, and compliance support

The BCP covers both onshore and remote operations.

Risk Scenarios Covered

CMPV’s BCP addresses potential risks including but not limited to:

  • Natural disasters (floods, earthquakes, pandemics)
  • IT system failures or cyber incidents
  • Power outages or infrastructure disruptions
  • Workforce unavailability
  • Regulatory or travel restrictions
  • Third-party service interruptions

Business Impact Analysis (BIA)

A structured Business Impact Analysis is conducted to:

  • Identify critical business processes
  • Define Recovery Time Objectives (RTO)
  • Define Recovery Point Objectives (RPO)
  • Prioritize pharmacovigilance activities impacting patient safety and compliance

Critical processes are classified and protected with predefined recovery strategies.

Continuity & Recovery Strategies

CMPV Consultancy LLP ensures resilience through:

  • Remote-ready workforce model
  • Secure cloud-based pharmacovigilance systems
  • Redundant IT infrastructure and data backups
  • Cross-trained pharmacovigilance professionals
  • Alternate communication channels
  • Controlled access to validated safety databases

IT & Data Protection

  • Regular automated data backups
  • Secure VPN and access-controlled environments
  • Data integrity checks and validation controls
  • Compliance with GDPR, local data protection laws, and confidentiality agreements

Crisis Management & Governance

A dedicated BCP Response Team is responsible for:

  • Incident assessment and escalation
  • Communication with clients and stakeholders
  • Activation of continuity measures
  • Monitoring recovery progress
  • Documentation and post-incident review

Roles and responsibilities are clearly defined and periodically reviewed.

Communication During Disruption

CMPV ensures transparent and timely communication through:

  • Predefined escalation and contact matrices
  • Client notification protocols
  • Regular status updates during incidents
  • Single-point contact for continuity coordination

Training, Testing & Review

  • Periodic BCP awareness training for employees
  • Mock drills and continuity testing
  • Continuous improvement based on lessons learned
  • Annual review or revision upon significant operational changes

Regulatory & Client Assurance

CMPV’s Business Continuity Plan is:

  • Available for client audits and regulatory inspections
  • Integrated into the Quality Management System
  • Aligned with global pharmacovigilance expectations
  • Designed to protect patient safety above all

Conclusion

CMPV Consultancy LLP is fully prepared to maintain uninterrupted pharmacovigilance and regulatory services, even during unforeseen disruptions. Our robust Business Continuity Plan ensures resilience, reliability, and regulatory confidence for our global clients.