Scalability
From a single review to global submission support, we scale effortlessly to meet your project needs.
IND Submissions, Done Right
Get FDA-ready Investigational New Drug applications delivered by regulatory experts trusted by biotech and pharma leaders. Complete pre-IND strategy, CMC documentation, nonclinical study summaries, and clinical protocol packages that accelerate your path to first-in-human studies. Not sure you're ready to file? Download our IND Readiness Checklist.
What We Do: Comprehensive IND Application Support
Criterion Edge provides end-to-end IND writing and regulatory support across the full IND lifecycle—from Pre-IND briefing packages to integrated nonclinical and clinical summaries, Investigator’s Brochure development, and CMC regulatory documentation. We partner with sponsors to translate complex development data into clear, FDA-aligned narratives that support first-in-human study authorization and confident regulatory decision-making.
Strategy, Readiness & Regulatory Support
- Regulatory consulting and development strategy
- Pre-IND meeting support (briefing packages and FDA engagement)
- Regulatory roadmapping and submission planning
- Risk identification and mitigation planning
Nonclinical Writing & Support
- Nonclinical overview
- Written and tabulated summaries of pharmacology, pharmacokinetic, and toxicology
- Integration and interpretation of PK/TK data
- Nonclinical content quality review
Clinical Writing & Trial Documentation
- Clinical protocols
- Investigator’s Brochures (IBs)
- Informed Consent Forms (ICFs)
- Clinical Study Reports (when prior clinical data exist)
- Clinical overview and summaries
CMC Writing & Regulatory Narratives
- CMC narratives and regulatory summaries
- Drug substance and drug product descriptions
- Stability, comparability, and control strategy summaries
Submission Compilation & FDA Support
- Cross-module content integration and consistency
- eCTD-ready document preparation and publishing support
- FDA information request and response support
Quality & Compliance Review
- Focused QC checklists
- Cross-module consistency and traceability reviews
- Regulatory compliance and submission readiness reviews
How We Work
Our Proven 5-Step Workflow
We combine regulatory strategy, scientific rigor, and execution speed to deliver IND submissions that are clear, compliant, and built for FDA review.
1
Program Scoping & Regulatory Alignment
We align early on product profile, indication, regulatory pathway, and FDA expectations—defining scope, timelines, and document strategy to support a successful IND.
Content Planning & Data Readiness Review
We assess available nonclinical, clinical, and CMC data to confirm readiness, identify gaps, and define the structure and level of detail required for each IND section.
2
3
Scientific Integration & Narrative Development
We develop clear, FDA-aligned narratives across nonclinical, clinical, and CMC sections, integrating pharmacology, toxicology, PK/TK, and manufacturing data into a cohesive regulatory story.
Quality Review & Compliance Check
Each IND undergoes structured quality and consistency reviews to ensure alignment with FDA guidance, internal data sources, and eCTD requirements.
4
5
Submission Finalization & FDA Support
We prepare the IND for eCTD submission and support FDA interactions during the 30-day review period, including responses to information requests and clarification questions.
IND Application Support
At Criterion Edge, we provide strategic, FDA-aligned IND writing support that helps sponsors move efficiently from preclinical development to first-in-human studies. Our approach combines regulatory insight, scientific rigor, and clear communication to support confident FDA engagement and clinical program initiation.
Dedicated Regulatory Medical Writers
Clients are supported by experienced regulatory medical writers who lead IND strategy, content development, and coordination across nonclinical, clinical, and CMC sections—ensuring a focused, defensible submission tailored to each program
Integrated Authoring Across IND Modules
We develop and integrate nonclinical, clinical, and CMC content within the IND and eCTD structure, ensuring consistency across study narratives, dose justification, safety rationale, and manufacturing descriptions, aligned with FDA guidance and current review expectations.
Predictable, High-Quality Execution
Our team synthesizes pharmacology, toxicology, PK/TK, clinical, and CMC data into clear, submission-ready narratives, supported by structured quality and compliance reviews to minimize FDA questions and avoid delays to clinical start.
Turning Development Data into Clinical Authorization
We translate complex scientific data into persuasive regulatory narratives that support first-in-human dosing, enable FDA review, and help sponsors advance their clinical programs with confidence.
Are You Ready for an Investigational New Drug Application?
From initial IND filings to amendments and safety updates, Criterion Edge delivers comprehensive IND documentation that meets FDA requirements and accelerates your path to clinical trials.
Am I ready for an IND?
- Identify documentation gaps across clinical, nonclinical, and CMC sections
- Assess the readiness of the protocol, IB, and supporting narratives
- Evaluate timeline and resourcing risks
- Prepare for FDA review with confidence
Where does IND writing support add the most value?
- Full IND authoring and document harmonization
- Protocol and IB finalization and alignment
- Cross-module consistency and QC
- IND amendments, information requests, and lifecycle maintenance
What distinguishes a high-quality IND submission?
- A coherent scientific narrative across modules
- Clear justification of starting dose, escalation, and safety monitoring
- FDA-aligned structure and level of detail
- Fewer review questions and smoother study initiation
A Team of experts at your service
Quality Assurance
Quality Assurance Manager
Medical Writers
PhD's, MD's, Scientists, Researchers
Literature Review Team
Medical Librarian, Clinical Evidence Experts
Project Oversight
Principal Writer / Strategic Leadership
Project Management
Project Management
A Purpose-Built Team for Every Project
Your literature review deserves more than just a freelancer. At Criterion Edge, each project is staffed with a dedicated, specialized team to ensure speed, consistency, and subject-matter accuracy.
Global Network of Experts
We tap into a distributed team with deep therapeutic and regulatory experience - working around the clock to move your project forward.
Specialized Roles, Unified Execution
You'll work with protocol developers, medical writers, and therapeutic-area experts aligned to your specific evidence needs.
Scalable, Flexible Staffing
Need to move faster or adjust scope? We scale resources up or down to meet your timeline and budget - without sacrificing quality.
Why Clients Choose Criterion Edge
We don't just check boxes - we partner with your team to deliver high-quality, submission-ready results. Here's what sets us apart:
Experience
Our team includes seasoned experts across regulatory, clinical, and therapeutic domains.
Quality
Built-in quality control ensures every deliverable is compliant, consistent, and audit-ready.
Efficiency
Streamlined workflows and dedicated project teams reduce turnaround time - without cutting corners.
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.
PAST AND UPCOMING WEBINARS
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Maximizing the Value of Literature Reviews in Pharma, From Competitive Intelligence to Market Success
Leveraging AI in Regulatory Writing — Opportunities, Oversight & What Medical Device Leaders Need to Know
HOT OFF THE PRESS
Why Leading MedTech & Pharma Teams Turn to Criterion Edge
Pharmaceutical, in-vitro diagnstics and medical device companies face growing pressure to deliver high-quality, compliant submissions on tight timelines - with limited internal resources. Criterion Edge was built to fill that gap.
Keeping Up With Regulatory Demands
Navigating evolving requirements like EU MDR and FDA guidance takes expertise and constant vigilance. We simplify the process for you.
Demanding Reliability from Partners
Late reports, misaligned expectations, or unclear deliverables waste valuable time. Our team is known for quality, clarity, and on-time delivery.
Working Within Tight Budgets
Internal writing teams can be costly and hard to scale. Outsourcing with us helps you meet your evidence goals while staying within budget.
Bridging the Talent Gap
Medical writing and regulatory expertise is niche and hard to hire. With decades of experience, our consultants, writers and reviewers are ready to support your projects right now.
Meet Our Founder: Laurie Mitchell, CEO
With over two decades in the pharmaceutical and medical device sectors, Laurie Mitchell founded Criterion Edge 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.
Under her leadership, Criterion Edge has supported top global brands across regulatory submissions, clinical strategy, and market access. 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.
Ready to Streamline Your Investigational New Drug Application Process?
Let’s discuss your Investigational New Drug Application needs and how Criterion Edge can support your strategic objectives.