Regulatory Strategy

Proven track record in successfully guiding sponsors through the ever-evolving Regulatory Landscape

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. 

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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.

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