Regulatory Strategy
Our Regulatory Strategy Solutions
NextGen R&D
Driving forward thinking R&D innovation
NextGen Regulatory
Creating the new normal in Regulatory affairs together with our clients
Strategic Sourcing Analysis
Building the business case for an effective sourcing model
Regulatory Process/Technology Assessment, Strategy, and Implementation
An integrated approach for effective results
Regulatory Information Management Maturity Model
A multi-dimensional tool to support a strategic path to RIM excellence and a single source of truth
End-to-End Labeling & Artwork Management
Ensuring oversight from signal to implementation
Regulatory Intelligence
Establishing Regulatory edge
With increasing emphasis on patient safety, your ability to manage product information and track and monitor safety throughout the life cycle requires fit-for-purpose strategies, including robust systems, processes, and governance.
Having accumulated a wealth of experience from 20 years of working in the industry, our consulting team can help you navigate the regulatory landscape as trusted advisors, providing strategic oversight, industry benchmarks, and insights. Our consulting engagements typically begin with a detailed current state assessment to identify and prioritize improvement opportunities and continue beyond pragmatic recommendations to include detailed solution design and implementation.
We can act as a bridge between IT and Regulatory across business functions due to our in-depth understanding, hands-on experience, and engagements across business functions, IT, and technology vendors, and service providers.
Our vast experience has taught us that there is no one-size-fits-all solution. We take an individualized approach to addressing the needs of each client to ensure results are grounded in industry best-practices, supported by our industry networks labelnet®, labelconnect®, labeltech®, and rimnet®, tailored to specific needs.
