Get audit-ready, regulatory-compliant documents delivered by PhD-level experts trusted by top medtech and pharma teams — from early-stage bench testing through post-market surveillance, across device, drug, and IVD pathways worldwide.
Our Service Areas
Criterion Edge offers specialized writing services across the entire product lifecycle — from regulatory submissions and clinical development to post-market obligations and strategic communications.
EU MDR · FDA 510(k) · PMA · De Novo
Comprehensive regulatory writing across the full medical device lifecycle — from IDE applications and technical documentation through CERs, post-market surveillance, and vigilance reporting.
IND · NDA/BLA · MAA · eCTD · ICH
Full-spectrum pharmaceutical writing from IND-enabling studies through NDA/BLA submissions, eCTD modules, clinical study reports, and post-approval safety reporting under ICH guidelines.
EU IVDR · FDA IVD · Performance Evaluation
Specialized IVD writing spanning IVDR technical documentation, analytical validation, performance evaluation reports, scientific validity assessments, and post-market performance follow-up.
PRISMA · Cochrane · GRADE · Meta-Analysis
Rigorous evidence synthesis supporting regulatory submissions and clinical evaluations — including systematic reviews, meta-analyses, network meta-analyses, and HTA submissions.
KOL · HEOR · Value Dossiers · Manuscripts
Strategic medical communications and publication support — from manuscript writing and congress materials to KOL presentations, value dossiers, HEOR reports, and patient education.
How We Work
We combine transparency, scientific rigor, and speed in every project. Our process ensures efficiency from first meeting to final report.
Collaboratively define scope, timelines, deliverables, and establish communication channels with your SMEs.
Review key source materials and map content to regulatory structure to ensure completeness and consistency.
Focused writing with proactive timeline management and collaborative engagement with stakeholders and SMEs.
Comprehensive QC including consistency checks, cross-references, and compliance with regulatory guidance.
Ongoing writing support during regulatory review, including responses to information requests and document updates.
At Criterion Edge, we specialize in delivering high-quality, submission-ready documentation that meets global regulatory requirements and supports efficient review and approval.
We author documentation aligned with FDA, EMA, ICH standards, and EU MDR/IVDR requirements. Our focus is on scientific rigor, clarity, and regulatory consistency.
Our writers integrate clinical, nonclinical, and manufacturing inputs into cohesive, well-aligned narratives with consistency across all document modules.
We deliver documents that are complete, internally consistent, and ready for inclusion in regulatory submissions. Our QC processes focus on traceability and compliance.
We support teams during regulatory review by preparing written responses to deficiency letters and information requests, and updating authored documents as needed.
Our People
PhDs, MDs, Scientists, Researchers
Principal Writer / Strategic Leadership
Project Manager
Medical Librarian, Clinical Evidence Experts
Quality Assurance Manager
Your regulatory documents deserve more than a freelancer. Each project is staffed with a dedicated, specialized team to ensure speed, consistency, and subject-matter accuracy.
We tap into a distributed team with deep therapeutic and regulatory experience — working around the clock to move your project forward.
You'll work with protocol developers, medical writers, and therapeutic-area experts aligned to your specific evidence needs.
Need to move faster or adjust scope? We scale resources up or down to meet your timeline and budget — without sacrificing quality.
We don't just check boxes — we partner with your team to deliver high-quality, submission-ready results. Here's what sets us apart:
From a single review to global submission support, we scale effortlessly to meet your project needs.
Our team includes seasoned experts across regulatory, clinical, and therapeutic domains.
Built-in quality control ensures every deliverable is compliant, consistent, and audit-ready.
Streamlined workflows and dedicated project teams reduce turnaround time — without cutting corners.
Average scores (out of 5) from post-project client surveys.
"Finalizing our protocol and working through the many drafts was a seamless process thanks to Criterion Edge."Sr. Director, Global Clinical Operations
"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 Research
"The project team was very collaborative and flexible. I was very satisfied with the quality of work."Sr. Director, Global Pharmacovigilance
"Very positive experience in all aspects. Exceeded our expectations."Executive Director, Clinical Development
Pharmaceutical and medical device companies face growing pressure to deliver high-quality, compliant evidence on tight timelines — with limited internal resources.
Navigating evolving requirements like EU MDR, FDA guidance, and PRISMA compliance takes expertise and constant vigilance. We simplify the process for you.
Late reports, misaligned expectations, or unclear deliverables waste valuable time. Our team is known for quality, clarity, and on-time delivery.
Internal writing teams can be costly and hard to scale. Outsourcing with us helps you meet your evidence goals while staying within budget.
Regulatory writing expertise is niche and hard to hire. Our experienced writers and reviewers are ready to support your projects right now.
With over two decades in the pharmaceutical and medical device sectors, Laurie Mitchell saw firsthand how regulatory and clinical teams struggled with evidence synthesis. She launched Criterion Edge to deliver high-quality documentation that bridges the gap between complex scientific data and actionable, submission-ready regulatory reports.
Under her leadership, Criterion Edge has supported top global brands across regulatory submissions, clinical strategy, and market access — providing expert-written, fully documented deliverables trusted by teams around the world.
Let's discuss your regulatory writing needs and how Criterion Edge can support your strategic objectives.
