YOUR PHARMA BIOLOGICS SCIENTIFIC REGULATORY WRITING PARTNER
PHARMA/BIOLOGICS WRITING SERVICES
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
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
A team of experts at your service
Researchers
Principal Writer / Strategic Leadership
Project Manager
Evidence Experts
Manager
Why Criterion Edge
Expertise
Expertise
Collaboration
Collaboration
Quality
Quality
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
Expertise
Expertise
Collaboration
Collaboration
Quality
Quality
Flexibility
Flexibility
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.
/ 5.00
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