Drug safety and Pharmacovigilance
Drug Safety & Pharmacovigilance Consulting for Global MAHs and Sponsors
Our drug safety and pharmacovigilance services support global compliance across ICSR management, signal detection, RMPs, PSMF, and PV audits aligned with US FDA, EMA, and MHRA. GPLACO SOLUTIONS delivers end-to-end Drug Safety and Pharmacovigilance consulting for Marketing Authorization Holders (MAHs), Sponsors, and CROs operating across the US, EU, UK, and other regulated markets. We design and govern inspection-ready pharmacovigilance systems covering ICSR processing, signal detection, benefit–risk management, RMP/REMS, QPPV oversight, and global safety governance. Our approach is regulatory-driven, risk-based, and lifecycle-focused, ensuring sustained compliance with EMA GVP, FDA, MHRA, PMDA, TGA, and ICH standards while protecting product value and patient safety.
Transforming Complexity into Compliance Excellence
Inspection-Ready Pharmacovigilance Systems Across the US, EU, UK & APAC
GPLACO SOLUTIONS delivers strategic drug safety and pharmacovigilance consulting for Marketing Authorization Holders (MAHs), Sponsors, and CROs operating in highly regulated global markets. We design and govern end-to-end pharmacovigilance systems that meet EMA, FDA, MHRA, PMDA, TGA, and ICH requirements, ensuring continuous inspection readiness and sustainable product lifecycles.
With over 18+ years of global pharmacovigilance leadership experience and oversight of 250+ medicinal products, GPLACO SOLUTIONS delivers inspection-ready drug safety services aligned with US FDA, EMA, and MHRA expectations. We support and provide expert Drug safety and Pharmacovigilance consulting and advisory for organizations across early development, clinical trials, post-marketing surveillance, and lifecycle management—transforming regulatory complexity into compliant, audit-ready operations.
ICSRs Monitoring & Medical Review
We provide full-lifecycle Individual Case Safety Report (ICSR) management from intake and triage to medical review and global regulatory submission. Our frameworks ensure data accuracy, regulatory timelines, and compliance, aligned with FDA, EU GVP Modules, MHRA, PMDA and TGA expectations.
✔ Assured 98%+ QA-verified ICSR quality across clinical and post-marketing cases
✔ 24–72 hour expedited reporting for Fatal/LT cases with zero missed regulatory timelines
Signal Detection & Evaluation
Our signal management frameworks integrate quantitative and qualitative analytics with expert medical judgment, enabling early detection of emerging safety information (ESI) and risks. We detect, validate, analyse and prioritize, for regulatory communication in line with GVP Module IX, FDA guidance, MHRA and ICH E2E.
Key outcomes:
✔ Aligned with global and local regulatory requirements through out the signal lifecycle management
✔ Medically validated through scientific and research backing through global sources and accurate signal decisions and tracking.
Aggregate Reporting & Benefit-Risk
GPLACO provides expert authoring and strategic oversight of PSUR, PBRER, DSUR, and PADER submissions. Our benefit–risk evaluations are inspection-ready, medically sound, and aligned with EMA, FDA, and PMDA expectations—resulting in minimal HA follow-up.Includes: Integrated benefit–risk evaluation DLP governance & global submission planning Regulatory response support
Safety Governance & QPPV oversight
We provide strategic EU-QPPV oversight, safety governance frameworks, and Safety Management Team (SMT) leadership. Our governance models ensure executive-level visibility, accountability, and regulatory defensibility across global portfolios.Governance coverage: QPPV & Deputy QPPV support Safety governance charters Escalation & decision frameworks
PSMF & GVP Inspection Readiness
We establish and maintain Pharmacovigilance System Master Files (PSMFs) and support the drafting and negotiation of SDEAs / PVAs, ensuring seamless global partner compliance aligned with EU GVP Modules I & II, MHRA and Inspection readiness expectations.
✔ Inspection-ready PSMFs aligned with EMA and MHRA expectations
✔ Zero critical inspection findings during inspections
Transforming Safety with AI/ML Integration
We streamline PV processes by automating manual tasks without sacrificing medical oversight. From Literature Review Automation to Risk Prediction Models, our technology-enabled approach enhances efficiency, ensures data integrity, and identifies safety signals earlier in the product lifecycle.
Literature Surveillance & Review Strategy
Systematic and thorough screening of global and local literature review process using popular databases - PubMed, Medline and Embase as required by GVP module VI and FDA guidance as well as applicable local regulatory requirements. We use AI-automated data mining to expedite signal identification and early implementation of Risk measures.
✔ 100% weekly precise literature screening using INN and active ingredients forbroad coverage and advanced searches - MeSH terms and search strings aligned with global expectations
✔ Zero missed ICSRs, IMEs, DMEs and special situations to ensure through analysis and dual screening for quality excellence,
PV Workflow, Volume projection & Resource allocation
Streamlining PV processes through Predictive AI models. We automate case prioritization and develop risk models to assess the likelihood of adverse events before they escalate.
Risk Management Plans (EU-RMP / US-REMS)
We design, develop and maintain EU Risk Management Plans (RMPs) and US REMS, based on therapeutic area, product safety specifications, labelling updates are aligned with global regulations and submission requirements ensuring risk minimization measures are proportionate and compliant.
Capabilities:
✔EU RMP and REMS sections are globally synchronised and eliminated multiple preparations and reviews.
✔Routine and additional RMM are implemented & effectiveness are verified
✔Robust PV Plan and minimal HA interactions & variations
Global PV Operations, Outsourcing & Vendor Oversight
GPLACO SOLUTIONS supports global PV operations including MICC, PVCC, literature surveillance, and partner oversight. We specialize in drafting, negotiating, and governing SDEAs and PVAs, ensuring clear safety responsibilities across sponsors, licensors, and CROs—reducing compliance risk in complex outsourcing models.
Drug Safety and Pharmacovigilance Consulting: Advantages of AI/ML-Enabled
Enhancing Patient Safety through Innovative Solutions
AI/ML enables instant adverse event detection for prompt responses.
Predictive analytics enhances effective identification and prioritization of safety signals.
Automated case triage and processing streamline pharmacovigilance workflows for consistent evaluations.
Predictive analytics ensures more accurate risk assessments, enabling targeted risk management strategies
Revolutionizing Patient Safety with EXPERT GPLACO Drug Safety and Pharmacovigilance Consulting
Consult with us to Ensure Utmost Patient Safety Through Innovative Pharmacovigilance Solutions.