Criterion Edge
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THE REGULATORY WRITING LITERATURE REVIEW SCIENTIFIC WRITING CLINICAL WRITING MEDICAL WRITING EXPERTS

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, MSN

President & Founder

Local Expertise, Global Coverage

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

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.

Why Criterion Edge

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.

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 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. The team was very flexible and ensured timely follow up with outstanding comments."
Sr. Director, Global Clinical OperationsPharmaceutical
"Emily 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. Nudrat understood quickly the important points to emphasize."
Associate Director, Clinical ResearchMedical Device
"The team was very collaborative and flexible. I was very satisfied with the quality of work."
Sr. Director, Global PharmacovigilancePharmaceutical
"It has been a pleasure working with the team 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

TALK TO AN EXPERT

Whether you’re looking for a 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.

How Can We Help?

We're headed to the 18th Annual Outsourcing in Clinical Trials New England · Visit Us At Booth 76A.

Clinical & Regulatory Writing Consultation

UPCOMING WEBINAR: Beyond AI: Why the Future of Scientific and Regulatory Writing Is Human + AI · October 28 · 8 AM PDT · 10 AM CDT · 11 AM EDT

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Criterion Edge
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