Global Pharmacovigilance Consulting services for MAHs, Sponsors and CROs, supporting GVP compliance, and inspection readiness. Bringing 18+ years of global PV expertise to ensure Safety, Efficacy and Quality.
Partner with GPLACO Solutions for strategic oversight and technical excellence in the complex global regulatory landscape.
Is Your Pharmacovigilance System Inspection-Ready — or Just Operational?
Regulatory scrutiny is intensifying across FDA, EMA, and MHRA inspections.
Most organizations struggle with fragmented global PV QMS structures, inconsistent signal governance, weak oversight documentation, and reactive compliance models.
Regulators Don’t Audit Intentions. They Audit Systems.
We Help PV Leaders To:
- Establish Global PV QMS aligned with GVP guidance documents and Regulations
- Strengthen global ICSRs collection, Benefit-Risk Governance Frameworks and Signal Evaluation & Risk Management (SERM)
- Design Inspection-Ready PV Systems for FDA, EMA & MHRA
- Conduct Independent GVP & Full PV System Audits
- Implement Sustainable CAPA & Regulatory Remediation Programs
- Provide Strategic Advisory to CROs on Quality, Productivity and Compliance challenges
About us
Shaping Global PV Strategy. Accelerating Market Success.
Founded by Dr Shripadaraja R, an industry leader with over 18 years of hands-on experience, GPLACO SOLUTIONS provides specialized strategic global pharmacovigilance consulting services and advisory for Marketing Authorization Holders (MAHs), Sponsors and CROs. Our expertise is rooted in shaping global Pharmacovigilance strategies across the US, UK, EU, and APAC regions.
With a proven track record of managing over 250+ products, we help our clients implement robust PV Quality Management Systems (QMS) and streamline complex processes. By establishing global ICSR case management, Literature surveillance, proactive Signal Detection, and Risk Management Plans (RMP) we identify early risks and mitigate them effectively contributing for Benefit-Risk and directly accelerating product approvals and commercialization.
Diverse Therapeutic Expertise:
Our strategic oversight spans a vast array of complex therapeutic areas, ensuring tailored safety solutions for every asset:
Oncology & Immuno-Oncology: Navigating complex safety signals in advanced cancer therapies.
Neurology & CNS: Specialized monitoring for chronic and degenerative conditions.
Cardiovascular & Metabolic: Managing high-volume data for global patient populations.
Rare Diseases & Orphan Drugs: High-touch safety strategies for small, critical patient cohorts.
Infectious Diseases & Vaccines: Rapid-response PV for emerging global health needs.
Immunology & Rheumatology: Long-term safety oversight for biologics and biosimilars.
Our Mission
Strengthening Global Pharmacovigilance Systems Through Strategic Advisory
Our mission is to support MAHs, Sponsors and CROs in building sustainable, inspection-ready pharmacovigilance systems through strategic governance, quality oversight and global regulatory compliance advisory.
Our Vision
Advancing a Future of Sustainable Pharmacovigilance Excellence
Our vision is to help organizations strengthen patient safety, operational quality and regulatory confidence through scalable pharmacovigilance governance and risk-based compliance frameworks.
Why Organizations Choose GPLACO SOLUTIONS
Organizations today require more than operational pharmacovigilance support — they need strategic governance, regulatory defensibility and sustainable compliance frameworks.
Our approach combines deep regulatory expertise with practical, risk-based pharmacovigilance strategies aligned with FDA, EMA, MHRA and PMDA expectations.
Phase I–IV leadership for 250+ products ensuring signal detection and Risk identification is integrated from Clinical Trials through to post-marketing.
Deep regulatory expertise across FDA, EMA, MHRA and PMDA environments supporting global pharmacovigilance compliance, inspection readiness and harmonized safety submissions.
250+ GVP audits executed, preparing MAHs, Sponsors and top CROs for successful global regulatory inspections readiness with no critical findings.
Comprehensive signal evaluation, benefit-risk assessment and risk management strategies designed to proactively identify, assess and mitigate safety risks across drugs and medical devices product lifecycle.
Establishing robust pharmacovigilance quality systems, governance frameworks and PSMF structures aligned with global regulatory expectations and inspection readiness requirements.
Enhanced Safety database features and integration with CTMS, QMS and streamlined regulatory safety operations. Improved Operational Efficiency & Compliance cross-functional data flow and lifecycle safety.
Strengthening pharmacovigilance oversight through risk-based vendor governance, compliance monitoring and sustainable quality management practices aligned with global regulatory expectations.
Helping organizations strengthen and streamline pharmacovigilance operations, improve vendor performance, reduce recurring challenges - quality, compliance, productivity and attrition across global safety operations.
Benefits and values
What You Gain with GPLACO SOLUTIONS
Global Drug Safety & PV Expertise – FDA, EMA, MHRA, PMDA and TGA
ICSR Case Management (End-to-End)
•98%+ QA-verified ICSR quality, assuring high quality
Literature Monitoring & Surveillance
•100% screening for valid ICSRs, Signals and Risks
Aggregate/Periodic Reports (PADER/ PSUR / PBRER / DSUR)
•100% on-time high-impact and quality reports submissions
Signal Detection & Management
•ICH E2E & GVP Module IX aligned global signal process
•Statistical analysis and validation from medical experts
RMPs Vs REMS expertise
•Global Proactive risk minimization and mitigation strategies supporting global approvals for products with minimal HA queries
PSMF Development & Maintenance
•Inspection-ready PSMFs aligned to EMA & MHRA expectations
•Zero critical inspection findings across global audits
PV QMS & GVP Audits Excellence
•Robust global PV QMS enabling risk-based compliance for MAHs, Sponsors, CROs and partners
•Risk-based assessment and global audit plan strategy tailored to your portfolio
Choosing GPLACO SOLUTIONS means gaining a strategic partner who goes far beyond support in discovery and clinical trials.
With 18+years of deep global experience, we help life sciences organizations plan, de-risk, and execute across the entire product lifecycle — from early development to post-approval.
Our core strength lies in world-class global pharmacovigilance consulting services, reinforced by robust regulatory strategy and quality assurance frameworks. We proactively assess safety, efficacy, effectiveness, benefit–risk balance, and risk mitigation, enabling informed decision-making at every critical milestone.
By embedding compliance, scientific rigor, and governance early, we help you:
Reduce downstream regulatory risk
Avoid costly delays and rework
Strengthen inspection readiness
Accelerate approvals, pricing, and market access
Our ultimate focus is simple and measurable: delivering safer, higher-quality medicines that meet global regulatory expectations and succeed in the real world.
Data accuracy and precision screening across clinical trials and Post-approval safety reporting
Assured Safety profiles with 100% DLP Regulatory submission and minimal Health Authority (HA) queries
Early detection of safety concerns with effective risk minimization measures ensuring product safety
Zero critical observations for MAHs and Sponsors across Regulatory inspections for FDA, EMA, MHRA, PMDA and TGA
Few Remarkable Accomplishments & Distinguished Milestones
Exploring GPLACO’s Commitment to Safer Medicines and Industry Advancements
Achieved a breakthrough by introducing process automation and innovative problem-solving strategies.
Demonstrated leadership in successfully spearheading complex projects, showcasing proficiency in resource and budget management.
Has innovatively used automation, artificial intelligence, and machine learning to address critical industry pain points.
Recognized for his profound expertise in addressing challenges related to data quality, adverse event management, signal detection, and risk assessment in the pharmaceutical domain.
Efficient Outsourcing Solutions
The company specializes in streamlining outsourcing processes for pharma and biotech companies, effectively addressing pain points associated with quality and compliance.
Whether you are an MAH, Sponsor or a CRO establishing a global PV system, preparing for FDA, EU & MHRA GVP audits, strengthening safety governance or expanding into regulated markets, GPLACO SOLUTIONS provides expert global pharmacovigilance consulting services that ensures sustainable regulatory compliance.
How we Strengthen Global Pharmacovigilance Systems?
We support MAHs, Sponsors and CROs in strengthening pharmacovigilance governance frameworks, inspection readiness and global regulatory compliance through strategic PV advisory and risk-based quality systems.
#1
Global PV QMS & Governance
Build Inspection-Ready PV Systems
We help organizations establish and strengthen global pharmacovigilance quality systems aligned with FDA, EMA, MHRA and global regulatory expectations.
Strengthen Governance & Oversight
Our advisory approach focuses on sustainable PV governance, procedural consistency, vendor oversight and inspection defensibility across global operations.
#2
ICSR, Literature & Aggregate Reporting
Strengthen End-to-End Safety Operations
We support organizations in optimizing ICSR management, literature surveillance and aggregate safety reporting processes aligned with global pharmacovigilance requirements.
Ensure Regulatory Compliance
Our expertise spans case quality management, medical review oversight, reconciliation governance and compliance across US, EU, UK and APAC markets.
#3
Signal Management & Benefit-Risk Governance
Proactive Risk Identification & Evaluation
We support signal detection, signal evaluation and benefit-risk governance frameworks aligned with lifecycle safety management and global regulatory expectations.
Strengthen Safety Decision-Making
Our approach enhances signal oversight, documentation quality, risk communication and regulatory defensibility across global pharmacovigilance systems.
#4
GVP Audits, PSMF & Inspection Readiness
Prepare for Regulatory Inspections
We conduct independent GVP audits and pharmacovigilance system assessments to strengthen inspection readiness across FDA, EMA, MHRA and APAC regulated environments.
Strengthen Compliance & System Defensibility
Our expertise includes PSMF oversight, CAPA remediation, vendor governance, risk management plans (RMPs) and regulatory inspection preparedness.