Pharmaceutical
- Clinical study reports (CSRs) and protocols
- INDs, NDAs, BLAs, and global marketing submissions
- Investigator’s brochures
- Safety documentation and pharmacovigilance reports
Expertly Written. Regulatory Ready.
From regulatory submissions and clinical study reports to literature reviews and published research, Criterion Edge delivers PhD-level medical report writing for the medical device, pharmaceutical, and diagnostics industries. One partner for every document, built to support compliance, stand up to review, and move your program forward.
Not ready to submit yet? Talk with one of our medical writing experts at no cost to learn what typically slows submissions down, what timelines to expect, and how to budget effectively or download our free Medical Writing Readiness Checklist.
Trusted by leading medtech, pharma & diagnostics teams
Criterion Edge provides comprehensive medical report writing across the entire product journey, covering pharmaceutical, medical device, and diagnostics programs, plus scientific publications and literature reviews. Explore the work we do in each area.
Average scores (out of 5) across the criteria we ask every client to grade us on after each project.
The quality of the medical writing was very good, with great attention to detail. The writer understood quickly the important points to emphasize.
It has been a pleasure working with Criterion Edge, and I have advised other companies to consider your services.
Finalizing our protocol and working through the many drafts was a seamless process thanks to Criterion Edge.
Emily has integrated into our team so well. She provides direction and leadership during our meetings to keep the team moving forward.
The project team was very collaborative and flexible. I was very satisfied with the quality of work.
Very positive experience in all aspects.
Exceeded our expectations.
We combine scientific precision, regulatory expertise, and efficiency to deliver high-quality documents from first scoping call to final submission, with clarity, consistency, and readiness at every stage.
We align early on objectives, regulatory pathway, target audience, and timeline to set a clear, defensible path forward.
We review all relevant source documents and map the data to the intended narrative so scope, strengths, and limitations are clear before drafting.
We draft comprehensive content aligned to the standards your submission has to meet, with every claim clearly tied back to the underlying data.
We run a thorough quality-control review, cross-checking against source data, statistical outputs, references, and regulatory requirements.
We deliver submission-ready documents and stay engaged for review responses, revisions, and updates across the lifecycle.
We combine regulatory expertise, scientific rigor, and clear documentation to support robust submissions, defensible evidence, and high-impact communications, whatever stage your program is in.
Every project is led by experienced PhD- and MD-level writers with deep therapeutic and regulatory knowledge matched to your document and indication.
We know the regulatory and scientific standards each document has to meet, and we write to them, so everything we deliver is well-structured, internally consistent, and ready for review.
We synthesize clinical, safety, statistical, and literature inputs into clear, balanced narratives that accurately reflect the data and its limitations.
Structured workflows, tight version control, and proactive collaboration mean on-time delivery without sacrificing scientific integrity.
We provide medical writing for whatever your program needs, at every point in the lifecycle, across every category of document, and for every milestone you’re working toward.
Medical writers, literature-review specialists, quality assurance, project oversight, and dedicated project management, all working together on your project.
From a single review to global submission support, we scale resources up or down to meet your timeline, scope, and budget.
A distributed network of seasoned PhD- and MD-level experts across regulatory, clinical, and therapeutic domains, aligned to your evidence needs.
Streamlined workflows and built-in quality control mean every deliverable is compliant, consistent, audit-ready, and on time.
Pharmaceutical, device, and diagnostics companies face growing pressure to deliver high-quality, compliant evidence on tight timelines, with limited internal resources. Criterion Edge was built to fill that gap with expert-led, scalable medical writing.
Regulatory and scientific requirements keep changing, and keeping up takes real expertise. We track the standards that apply to you and navigate the pathway for you, whatever the document.
Regulatory and scientific requirements keep changing, and keeping up takes real expertise. We track the standards that apply to you and navigate the pathway for you, whatever the document.
Regulatory and scientific requirements keep changing, and keeping up takes real expertise. We track the standards that apply to you and navigate the pathway for you, whatever the document.
Regulatory and scientific requirements keep changing, and keeping up takes real expertise. We track the standards that apply to you and navigate the pathway for you, whatever the document.
With over two decades in the pharmaceutical and medical device sectors, Laurie Mitchell saw firsthand how regulatory and clinical teams struggled with reviewing evidence and communicating science clearly. She launched Criterion Edge to deliver high-quality medical writing that closes the gap between complex science and clear, submission-ready documentation.
Under her leadership, Criterion Edge has supported top global brands across regulatory submissions, clinical strategy, literature reviews, and market access, providing expert-written, fully documented deliverables trusted by teams around the world.
Let's discuss your medical writing needs across any service area, and how Criterion Edge can support your strategic objectives.