Proven Expertise. Enhanced Compliance.
Our team understands your challenges because we’ve worked inside pharmaceutical and biotech organizations worldwide. As engineers, systems analysts, trainers and subject matter experts, we’ve experienced firsthand how pharmacovigilance reporting and compliance impact company success. This insider perspective allows us to optimize your drug safety software solutions in ways that align with real operational needs.
Led by managing partner Kenneth Nordeen, who brings over three decades of specialized pharmacovigilance expertise including Oracle Argus Safety implementations, system validations, and regulatory compliance across pharmaceutical companies of all sizes, Mozaic’s customized compliance solutions deliver measurable results: enhanced data consistency, streamlined operations, improved audit readiness, and reduced compliance risks across your product lifecycle. Our approach centers on three core strengths:
Proven Technical Excellence
Decades of pharmaceutical operations and technical system administration experience, including expertise in Argus Safety upgrades, E2B mappings, signal detection systems, and business configuration inform our customized, validated solutions. Every system meets 21 CFR Part 11/Annex 11 compliance standards while maximizing operational benefits through expert pharmacovigilance database management and global regulatory knowledge.
Reliable Partnership
From system validation through regulatory inspections, we provide consistent support when you need it. Our team offers assistance throughout your product lifecycle, ensuring your drug safety compliance remains strong at every stage.
Adaptable Investment Models
Choose the pricing structure that fits your operational volume and budget planning preferences. Time and materials models work well for routine system changes and analytical support, while fixed-price options provide budget certainty with major system modification projects.
Putting the Pieces Together
Just as individual tiles create a beautiful mosaic, we assemble every element of your drug safety compliance into a complete, unified picture. We connect all vital pieces to defend your product and secure your organization’s future. Through decades of pharmacovigilance expertise across multiple disciplines, we transform complex regulatory challenges into integrated solutions.