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YOUR REGULATORY SCIENTIFIC CLINICAL MEDICAL WRITING PARTNER

Criterion Edge is dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and IVD companies through industry leading writing services.

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About Criterion Edge
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WHAT CAN WE HELP YOU WITH?

In-Vitro Diagnostics Writing

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Medical Device Writing

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Pharma / Biologics Writing

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Systematic Literature Reviews

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CRITERION EDGE

Criterion Edge was founded in 2016 with the goal to build a world-class team of industry experts dedicated to providing regulatory support and comprehensive writing services to pharma, biotech and device clients worldwide.

Today, Criterion Edge has grown into a recognized leader, trusted by clients ranging from ambitious start-ups to some of the largest companies in the world, but our dedication to quality, scientific rigor and regulatory excellence has not changed.

Laurie Mitchell, MN

President & Founder

Local Expertise, Global Coverage

Learn More About Criterion Edge

A team of experts at your service

Medical Writers
PhD’s, MD’s, Scientists,
Researchers
Project Oversight

Principal Writer / Strategic Leadership

Project Management

Project Manager

Literature Review Team
Medical Librarian, Clinical
Evidence Experts
Quality Assurance
Quality Assurance
Manager

Our Commitment To you

Expertise

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

Collaboration

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

Quality

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.

Flexibility

Flexibility

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.

Why Criterion Edge

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.
Experience our collaborative and partner-centric approach that blends your insights with our expert writing services to produce tailored regulatory documentation.
Reduce revisions and accelerate approval timelines with our rigorous quality control processes and experienced writers that produce superior drafts that meet global regulatory standards.

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.

How we exceed your expectations

Project Scoping & Planning

  • Define the scope of the project
  • Outline timelines for deliverables
  • Clarify roles and responsibilities
  • Establish communication channels with SMEs

Document Development

  • Focused document development
  • Proactive timeline management
  • Collaborative engagement with stakeholders/SMEs

Review Process

  • Roundtable leadership
  • Management of action items
  • Structured review reminders

Finalization & Delivery

  • Client-tailored close out process

what to expect: continuous collaboration

Project Scoping & Planning

  • Define the scope of the project
  • Outline timelines for deliverables
  • Clarify roles and responsibilities
  • Establish communication channels with SMEs

Document Development

  • Focused document development
  • Proactive timeline management
  • Collaborative engagement with stakeholders/SMEs

Review Process

  • Roundtable leadership
  • Management of action items
  • Structured review reminders

Finalization & Delivery

  • Client-tailored close out process

What our clients have to say

Survey Responses

Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
Flexibility
0
Quality
0
Expertise
0
Timeliness
0
Collaboration
0
Communication
0
Overall
0

/ 5.00

"Finalizing our protocol and working through the many drafts was a seamless process thanks to Criterion Edge.
Sr. Director, Global Clinical OperationsPharmaceutical
"Emily [Project Supervisor] has integrated into our team so well. She provides direction and leadership during our meetings to keep the team moving forward."
Associate Director, Clinical OperationPharmaceutical
"The quality of the medical writing was very good, with great attention to details. The writer understood quickly the important points to emphasize."
Associate Director, Clinical ResearchMedical Device
"The project team was very collaborative and flexible. I was very satisfied with the quality of work."
Sr. Director, Global PharmacovigilancePharmaceutical
The project team was very flexible and ensured timely follow up with outstanding comments."
Sr. Director, Global Clinical OperationsPharmaceutical
"It has been a pleasure working with Criterion Edge and I have advised other companies to consider your services."
R&D ManagerMedical Device
"Very positive experience in all aspects. Exceeded our expectations."
Executive Director, Clinical DevelopmentPharmaceutical
"Everyone was great to work with! They were very flexible with our timelines and our questions and feedback."
Regulatory SpecialistMedical Device

PAST AND UPCOMING WEBINARS

ALL WEBINARS

Maximizing the Value of Literature Reviews in Pharma, From Competitive Intelligence to Market Success

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Leveraging AI in Regulatory Writing — Opportunities, Oversight & What Medical Device Leaders Need to Know

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Maximizing the Value of Literature Reviews for IVD, From Competitive Intelligence to Market Success

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HOT OFF THE PRESS

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TALK TO AN EXPERT

Whether you’re navigating a complex regulatory submission, preparing for an audit, or simply exploring outsourced support — our team is here to help.

Criterion Edge specializes in high-quality, compliant medical writing services for the life sciences industry. Use the form to tell us a bit about your needs — one of our experts will follow up within one business day.

Need a faster response? Use the chat icon in the lower-right corner to speak with us immediately during business hours.

  • No obligation — just an open conversation
  • Expert guidance from PhD-level writers
  • Trusted by leading MedTech & Pharma companies
  • Fast turnaround for time-sensitive projects
  • Clear quotes and scoping available

How Can We Help?

REGISTER FOR OUR UPCOMING WEBINAR

In the pharmaceutical industry, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions, but as a strategic foundation for drug development, clinical trial design,

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