Pharmacovigilance plays a vital role across the life cycle of a medicine. In 2025, Lambda Therapeutic Research supports pharmacovigilance activities across a wide range of products and regulatory regions, helping sponsors meet drug safety requirements at different stages of development. Take a look at how we’ve contributed to Pharmacovigilance in 2025.
📊 Year 2025 at a glance:
- Literature articles reviewed: 543,291
- ICSRs processed: 90,095
- MICC queries handled: 9,963
- PADERs submitted: 420
- PSUR / ASR / DSURs / ACOS: 232
- RMP / REMS activities: 225
- Signal detection reports: 1,282
- Health hazard assessments: 122
- PSMFs maintained: 60
- xEVMPD entries: 2,309
✅Regulatory and audit support:
- Regulatory inspections supported: 12 [MHRA (4), US FDA (3), Belgium Authority, Hungary Authority, Swissmedic, SAHPRA, TGA]
- Client audits handled: 23
- Internal, vendor, and partner audits by PV QA: 18
Let’s discuss your Pharmacovigilance Needs
Choosing the right Pharmacovigilance partner is crucial for achieving both regulatory assurance and operational efficiency. 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. Lambda stands out through its:
- Proven compliance record across multiple MAHs and therapeutic categories
- Robust communication and reporting framework with competent authorities
- Inspection-ready systems aligned with EMA and MHRA requirements
- Client-specific approach, ensuring adaptable oversight based on risk level and portfolio complexity
- Integrated EU and UK coverage supported by locally based QPPVs
By combining regional expertise with global best practices, Lambda offers a complete pharmacovigilance governance solution that supports both innovators and generics manufacturers.
Connect with us to discuss how we can support your safety operations with the right strategy and infrastructure in place.