Clinivation

Overview

Clinivation is the leading provider of integrated solutions that enable global market clearance. Guided by our singular vision- "Excellence in Market Clearance"- clinivation accelerates the entire market clearance cycle to advance new worldwide revenue and achieve new milestones of enterprise value.

Used in over 1,000,000 product registrations by more than 100 companies worldwide, clinivation's end-to-end technology and services deliver on our vision by eliminating revenue traps from global market clearance operations, increasing process velocity with on-demand regulatory intelligence, automating clearance-driven business controls, simplifying content unification into market clearance applications, aligning quality systems with global market clearance priorities, streamlining clinical development with clearance-focused trials, and enabling management with key performance indicators for continuous improvement and effective governance.

Standards & Methodologies

Clinivation's market clearance services and solutions address >99% of the world markets for medical devices and diagnostics. Our qualifications and experience enable us to solve the industry's most difficult market clearance challenges. Accordingly, our core skills comprise international and domestic regulatory affairs, quality, engineering, clinical development, manufacturing, formulation, pharmaceuticals, biotechnology, biologics, nutraceuticals, and information technology. Our staff is fluent in many languages.

Qualifications, Certifications, Accreditations & Licenses

Our professional staff holds certifications and licensures in medicine, surgery, clinical research, regulatory affairs, quality auditing, quality engineering, information technology (systems and applications), and accounting.

Our software is certified to meet or exceed the requirements of 21CFR Part 11, HIPAA, and numerous worldwide privacy and quality standards.