Global ICSR Consulting experts & Literature Surveillance specialists for Global MAHs (US, EU, UK)
From compliance risk to inspection-ready operations
GPLACO SOLUTIONS are one of the top ICSR consulting experts specializing in ICSRs processing and Quality management for the USFDA, EMA and MHRA processes, we help MAHs and Sponsors transform complex ICSR workflows into compliant, efficient, and inspection-ready operations with a proven track record of achieving overall project quality scores >95%. Quality Improvement plan and establishment of effective global workflow and management is our strong suite.
Challenge:
Global ICSR reconciliation across multiple regional partners was inconsistent, leading to compliance gaps, delayed submissions, and increased inspection exposure. Literature monitoring was time-consuming and lacked automation.
Solution:
Standardized reconciliation frequency and processes across all partners → full global compliance.
AI-assisted ICSR tracking, case quality, and productivity tools → +22% efficiency.
Optimized literature surveillance with AI retrained on PubMed and MEDLINE → +28% article screening.
Result:
Full global ICSR reconciliation compliance achieved.
Productivity and case quality improved.
Faster detection of critical literature supporting regulatory submissions.
Our mastery in ICSR consulting includes end-to-end case management covering:
- ICSR Processing: Structured case intake, triage, and prioritization across global safety partners
- Medical Coding Excellence: Accurate MedDRA and WHO-DD coding aligned with regulatory expectations
- Clinical Assessment: Robust seriousness, expectedness, and causality assessment by experienced safety professionals
- Quality Review: Independent quality checks embedded into the workflow to consistently achieve >95% project quality scores
- Narrative Excellence: Clear, medically sound case narratives supporting regulatory clarity and inspection readiness
- Regulatory Submissions: Timely and compliant submissions to US FDA, EMA, MHRA, and global health authorities
This mastery enables MAHs and Sponsors to transform high-volume, multi-partner ICSR operations into controlled, inspection-ready safety systems—without compromising data quality or regulatory confidence.
Contact for Strategic Consulting & Advisory: contactus@globalplacosolutions.com
Visit for more information – www.Globalplacosolutions.com/ourexpertise/drug-safety-pharmacovigilance