Top Pharmacovigilance Outsourcing for US & EU Biopharma Sponsors
Bridging the gap between global scale and local regulatory precision.
For US and EU-based sponsors, the regulatory landscape is more than a hurdle—it is a moving target. With the 2026 updates to EMA GVP modules and the FDA’s heightening focus on Post-Market Safety Surveillance, “checking the box” is no longer enough. GPLACO Solutions provides specialized Pharmacovigilance Outsourcing tailored for small-to-mid-sized sponsors who require FDA Inspection Readiness and absolute EMA GVP Compliance without the overhead of a large CRO.
Small and mid-sized sponsors often face a “Service Gap” with large providers.
We close that gap by providing:
Local QPPV & LRPP Support: Seamless integration into EU and UK markets.
Audit-Ready PSMFs: We don’t just manage data; we build the Pharmacovigilance System Master File (PSMF) to survive the most rigorous EMA inspections.
FDA-Aligned Signal Management: Utilizing AI-enhanced tools to identify safety signals before they become regulatory “Refusal to File” issues.
Ensuring FDA & EMA Inspection Readiness
Our consultancy is built on the philosophy of “Constant Readiness.” We specialize in:
Gap Analysis: Identifying vulnerabilities in your current safety database before the regulators do.
Mock Inspections: Simulating FDA and EMA audits to train your team and refine your SOPs.
Corrective and Preventive Actions (CAPA): Streamlined remediation for existing findings.
Ensure your safety infrastructure scales with you. Book an Inspection Readiness Consultation