THE MEDICAL SCIENTIFIC REGULATORY WRITING EXPERTS

Criterion Edge provides best in class regulatory writing services for the Medical Device, Biopharma/Pharma, and In-Vitro Diagnostic Device industries. 

HOW CAN WE HELP?

MEDICAL DEVICE WRITING

IN-VITRO DIAGNOSTICS WRITING

PHARMA / BIOLOGICS WRITING

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.

WHERE IT ALL BEGAN...

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LAURIE MITCHELL
PRESIDENT | FOUNDER

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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