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YOUR PHARMA BIOLOGICS SCIENTIFIC REGULATORY WRITING PARTNER

PHARMA/BIOLOGICS WRITING SERVICES

Our team of experienced writers and medical librarians specialize in creating high-quality, pressure tested, compliant documentation essential for regulatory submissions and scientific communications.

Clinical Research Support

  • Clinical Study Report (CSR)
  • Investigator's Brochure (IB)
  • Clinical Study Protocols
  • Patient Safety Narratives
  • Pre-Clinical & CMC Writing
  • Scientific Abstracts, Posters, & Manuscripts
  • Annual Update Reports

Regulatory Submissions & Other Services

  • Briefing Documents & Meeting Support
  • Biologics License Application (BLA)
  • Investigational New Drug (IND)
  • New Drug Application (NDA)
  • eCTD Modules: 2, 4, and 5
  • Independent QC Review
  • HCP/Lay Summaries
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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

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.

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 team was very collaborative and flexible. I was very satisfied with the quality of work."
Sr. Director, Global PharmacovigilancePharmaceutical
"Very positive experience in all aspects. Exceeded our expectations."
Executive Director, Clinical DevelopmentPharmaceutical
The project team was very flexible and ensured timely follow up with outstanding comments."
Sr. Director, Global Clinical OperationsPharmaceutical
"Everyone was great to work with! They were very flexible with our timelines and our questions and feedback."
Regulatory SpecialistPharmaceutical

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?

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