Pharmacovigilance Beyond Compliance
Pharmacovigilance is no longer limited to meeting regulatory requirements. It has become a strategic function that enables sponsors to identify safety signals early, maintain global compliance, and protect patients throughout the product lifecycle.
As clinical development expands across multiple regions and regulatory expectations continue to evolve, sponsors need pharmacovigilance partners capable of delivering accurate, timely, and scalable safety services.
During the first half of 2026, Lambda Therapeutic Research continued to support global pharmaceutical, biotechnology, and medical device companies with comprehensive pharmacovigilance solutions across safety case processing, literature surveillance, aggregate reporting, signal management, regulatory documentation, and quality assurance.
H1 2026 at a Glance
Between January and June 2026, our Pharmacovigilance team achieved significant operational milestones:
| Service | H1 2026 |
|---|---|
| Literature Articles Reviewed | 271,896 |
| Individual Case Safety Reports (ICSRs) Processed | 48,979 |
| Medical Information Queries Managed | 6,563 |
| Risk Management Plans (RMPs) / REMS Processed | 151 |
| Periodic Safety Reports (PSUR, ASR, DSUR, ACOS) | 139 |
| PADERs Prepared | 133 |
| Health Hazard Assessments | 61 |
| Signal Detection Reports | 653 |
| Pharmacovigilance System Master Files (PSMFs) | 30 |
| xEVMPD Entries Managed | 1,006 |
| Client Audits Supported | 9 |
| Internal / Vendor / Business Partner Audits | 9 |
| Regulatory Inspections | 2 |
These milestones reflect the scale and consistency of our global pharmacovigilance operations.
Delivering High-Quality Case Processing
Accurate and timely Individual Case Safety Report (ICSR) processing remains the foundation of an effective pharmacovigilance system.
Our teams managed 48,979 ICSRs while maintaining compliance with global regulatory requirements and client-specific workflows. From data intake and medical review to coding, quality control, and regulatory submission, each case contributes to a stronger safety profile for marketed and investigational products.
Supporting Continuous Safety Surveillance
Effective literature monitoring plays an important role in identifying emerging safety information.
During the first six months of 2026, our specialists reviewed more than 271,000 scientific literature articles, helping sponsors identify reportable adverse events, monitor benefit-risk profiles, and meet global regulatory obligations.
Combined with 653 signal detection reports, these activities support proactive safety surveillance throughout the product lifecycle.
Comprehensive Regulatory Reporting
Global pharmacovigilance requires extensive regulatory documentation to demonstrate ongoing benefit-risk evaluation.
Our teams successfully prepared:
- 139 Periodic Safety Reports (PSUR, ASR, DSUR, ACOS)
- 133 PADERs
- 151 Risk Management Plans (RMPs) and REMS deliverables
- 30 Pharmacovigilance System Master Files (PSMFs)
- 1,006 xEVMPD entries
These submissions support compliance across multiple regulatory jurisdictions while enabling sponsors to maintain product registrations and meet post-marketing obligations.
Supporting Medical Information Services
Medical information is often the first point of interaction between healthcare professionals, patients, and product safety teams.
During H1 2026, Lambda managed 6,563 medical information queries, providing accurate, scientifically balanced, and timely responses while ensuring compliance with pharmacovigilance reporting requirements.
Quality Built into Every Process
Quality management is fundamental to pharmacovigilance.
During the reporting period, our quality teams supported:
- 9 client audits
- 9 internal, vendor, and business partner audits
- 2 regulatory inspections by EMA (European Union) and CDSCO (India)
These activities demonstrate the strength of our quality systems and our readiness to support sponsors during regulatory inspections and client audits.
A Global Partner for Pharmacovigilance
Lambda Therapeutic Research provides end-to-end pharmacovigilance services supporting pharmaceutical, biotechnology, generic, biosimilar, consumer healthcare, and medical device companies worldwide.
Our capabilities include:
- Case Processing (ICSR Management)
- Literature Surveillance
- Medical Information Services
- Aggregate Report Writing
- Signal Detection and Signal Management
- Risk Management Plans (RMPs)
- REMS Support
- PSMF Management
- xEVMPD Management
- Health Hazard Assessments
- Pharmacovigilance Quality Assurance
- Regulatory Compliance Support
- QPPV Services for EU and UK
- Safety Database Management
Partner with Lambda Therapeutic Research
Whether you require support for clinical trial safety, post-marketing pharmacovigilance, aggregate reporting, risk management, or global regulatory compliance, our experienced pharmacovigilance teams provide scalable solutions tailored to your development program.
Learn more about our Pharmacovigilance services:
https://www.lambda-cro.com/capabilities/clinical-safety-pharmacovigilance/
