See how Lambda helped a global pharma client overcome Pharmacovigilance (PV) challenges after rapid portfolio expansion by restoring compliance, improving efficiency, and enabling scalable safety operations.

Overview

A global pharmaceutical client underwent significant expansion, growing its product portfolio from 200 to over 400 INNs following a series of acquisitions and increased global dossier filings. This rapid growth placed substantial pressure on their pharmacovigilance and medical information (MI) infrastructure, resulting in operational and compliance challenges.

Key challenges included:

• Limited internal bandwidth
• Limited global regulatory expertise
• Challenges in cross-reporting of valid ICSRs
• Operational inefficiencies in meeting PV obligations
• Regulatory observations citing non-compliance and quality issues

Lambda’s Strategic Approach

Lambda’s Pharmacovigilance team collaborated with the client to stabilize operations and build a compliant, scalable, and efficient PV system. The engagement focused on four core areas:

Gap Analysis and PV Planning

• Reviewed existing PV processes to identify operational and compliance gaps • Developed a detailed PV management plan with clear roles, responsibilities, and timelines

Operational Strengthening

• Defined KPIs for all PV deliverables to monitor and drive performance • Deployed a dedicated QPPV to strengthen oversight • Designed a risk assessment and mitigation strategy • Centralized communication through a unified SharePoint platform

Infrastructure and Scalability

• Upscaled resources to manage increased volume • Implemented tracking systems for product approvals and withdrawals • Established a centralized global MI call center to streamline query management

Governance and Client Collaboration

• Initiated regular project steering and executive committee meetings • Provided transparent performance dashboards for review and discussion • Maintained ongoing engagement through structured feedback with the client’s PV team

Outcome:

• Achieved full compliance and met quality benchmarks as per agreed KPIs
• No critical observations during client audits and regulatory inspections
• Automated processes helped reduce costs despite increased case volumes
• Additional PV functions were transitioned to Lambda based on demonstrated performance
• The client was able to redirect internal resources to core business priorities, with PV responsibilities effectively managed by Lambda

Impact Delivered:

Lambda’s structured transformation enabled a global pharmaceutical client to improve oversight, reinforce compliance, and establish scalable, cost-effective pharmacovigilance operations.

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Let’s discuss your Pharmacovigilance Needs

Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.

Considering outsourcing pharmacovigilance activities? With evolving regulatory expectations and growing case volumes, having the right partner matters. Lambda’s experienced pharmacovigilance team supports global pharma and biotech companies with solutions that are compliant, scalable, and aligned with regulatory standards.

Connect with us to discuss how we can support your safety operations with the right strategy and infrastructure in place.