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Strategic Pharmacovigilance Consulting, QA & Regulatory Excellence
GPLACO Solutions provides Strategic Pharmacovigilance consulting, Quality Assurance (QA), and Regulatory expertise to global pharmaceutical and biotech organizations navigating high-risk, high-stakes regulatory environments. From early discovery risk profiling to global market authorization and lifecycle management, we integrate deep regulatory intelligence with AI-enabled execution to protect product value and accelerate approvals across the US (FDA), EU (EMA), UK (MHRA), and APAC (PMDA, TGA).
Our work eliminates the Health Authority Inquiry Loop, reduces inspection exposure, and ensures submission success for complex drug and medical device portfolios.
Success in late-stage development is determined early. We support discovery and preclinical teams with regulatory-viable safety intelligence that prevents costly downstream failures.
Strategic Impact & Results Achieved
• Safety profiling for 250+ products (drugs & medical devices) across oncology, CNS, rare diseases, vaccines, biologics, and combination products
• Early identification of high-risk safety liabilities prior to IND-enabling investment
• Discovery programs aligned upfront with future FDA IND, EU CTA, and ICH expectations
We bridge the operational gap between clinical development and Pharmacovigilance, ensuring safety data generated in trials is inspection-ready and submission-aligned.
Strategic Impact & Results Achieved
• Safety leadership across 200+ global clinical studies (Phase I–IV) with zero data integrity findings
• Safety-centric protocol design, Investigator Brochure authoring, and Initial Safety Profiles
• No PV-driven clinical holds attributable to system or governance failures
We deliver regulatory strategy with execution discipline, ensuring submissions withstand scrutiny from first filing to post-approval lifecycle management.
Strategic Impact & Results Achieved
• Support for INDs, NDAs, BLAs, CTAs, and MAAs across FDA, EMA, and MHRA pathways resulting in successful approvals
• On-time delivery of DSURs, PSUR/PBRERs, and PADERs with minimal Health Authority follow-up
• Proactive mitigation of Refusal-to-File and clinical hold risks
Our Pharmacovigilance frameworks are designed for scale, inspection readiness, and executive visibility — not just compliance.
Strategic Impact & Results Achieved
• 2M+ ICSRs processed with sustained >95% quality performance
• Signal detection, validation, and assessment of 100+ emerging safety concerns
• Benefit–Risk assessments conducted for 150+ products
• Design and implementation of EU-RMPs and US-REMS for 100+ products
We developed and implemented inspection ready global PV QMS inspection-ready Quality Systems across various regions and product lifecycles.
Strategic Impact & Results Achieved
• 200+ global GVP audits and due diligence engagements completed
• Zero critical findings across FDA, EMA, and MHRA inspections
• End-to-end QMS, PSMF, SOP, CAPA, and vendor oversight frameworks
We apply AI/ML where it matters most — data integrity, system interoperability, and regulatory confidence.
Strategic Impact & Results Achieved
• Seamless integration of EDC, CTMS, Argus, ARISg safety environments
• Zero data loss during complex safety database migrations and ETL transformations
• Elimination of reconciliation errors and inspection exposure caused by fragmented systems