Pharmacovigilance

Overview

SPR Solutions offers end-to-end PV services with a business-centric and problem solving focus to ensure regulatory compliance, best practices and maximum efficiency.

Our team has an average of over 15 years of life science experience. Each and every one of our professionals come with strong technology and/or business skills, a deep understanding of the drug safety process including industry best practices and excellent communication skills.

At SPR Solutions, we have performed over 200 safety system implementations, upgrades and data migrations and also help organizations manage their drug safety applications more accurately and confidently. We take pride in not only providing services to meet current regulatory compliance requirements but also positioning our clients to be prepared for future developments. Furthermore, by applying our proven methodology we minimize the impact of system implementations, upgrades and migrations both from the cost perspective as well as the impact on your team’s resources all while ensuring strict compliance to operational and regulatory requirements.

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Safety Implementation & Upgrade

We have an average of over 200 combined Argus implementation, database upgrade and data migration project experience involving Argus, Argus Japan, ARISg and E2B Pilots with regulators.

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E2B R2 & R3 Offerings

We have lead E2B(R2,R3) regulatory pilots with FDA, EMA, Health Canada, PMDA and China. We support planning, test registration and formal testing process for both CROs and Pharma clients.

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Data Migration

We have proven data migration methodologies and accelerators including DM mappings, code, and DM scripts to help our clients execute projects at a low cost and risk all with no compromise in quality.

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Compliance, SOP, Work Instructions

In order to ensure compliance with 21 CFR Part 11, EMA, PMDA and ICH guidelines, we support with full system and process audits. We also develop SOPs for data management, reporting and other processes.