ABOUT CRITERION EDGE

A COMMITTMENT TO REGULATORY EXCELLENCE

Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success through expert regulatory, scientific, and medical writing services. With deep expertise and comprehensive industry knowledge, we deliver specialized solutions that streamline the full product lifecycle for medical device, pharmaceutical, and IVD companies—from initial concept to post-market activities. 

Our integrated approach combines rigorous scientific and regulatory standards with strategic insight, offering a suite of services that includes regulatory and quality consulting, clinical trial support, and systematic literature reviews. At Criterion Edge, we are committed to providing solutions that not only meet but surpass the requirements of our clients, ensuring their innovations achieve both compliance and competitive edge in the marketplace. 

By fostering a culture of collaboration and quality, Criterion Edge empowers clients to navigate the complexities of the regulatory landscape effectively, ensuring a smoother path to commercialization and sustained market presence. 

WHY CHOOSE CRITERION EDGE?

EXPERTISE

Achieve high-quality, compliant written deliverables with our deep bench of seasoned regulatory writers and medical librarians that have specialized degrees and extensive therapeutic area knowledge.

COLLABORATION

Experience our collaborative and partner-centric approach that blends your insights with our expert writing services to produce tailored regulatory documentation.

QUALITY

Reduce revisions and accelerate approval timelines with our rigorous quality control processes and experienced writers that produce superior drafts that meet global regulatory standards.

SCALABILITY

Take advantage of our flexible staffing model that scales to match project demands, providing the regulatory experts required to meet your evolving needs without delay.

READY TO START YOUR NEXT PROJECT?

Whether you’re looking for a regulatory, medical and/or scientific writing partner; or just want to price shop a potential project – we’d love to connect. Fill out the form and someone from our team will be in touch within one business day. 

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