Regulatory Strategy
Global regulatory consulting for digital health technologies, software as a medical device classification, COA/DDT qualification, and clinical endpoint strategy. We work across FDA, EMA, and Health Canada.
The regulatory landscape for digital health and CNS clinical measurement is evolving rapidly across every major market. The FDA, EMA, and Health Canada are each developing frameworks for digital endpoints, software as a medical device, and AI-driven clinical tools. The differences in expectations, timelines, and evidentiary standards across these agencies are meaningful.
Sponsors who understand this landscape and engage proactively with regulatory bodies will gain significant advantages over those who treat regulatory strategy as an afterthought. This is particularly true for digital biomarkers and clinical outcome assessments, where the qualification and clearance pathways are still being defined.
We bring deep specialization in the intersection of regulatory science and CNS clinical measurement. Our focus areas include COA/Drug Development Tool qualification pathways, 510(k) and de novo device clearance strategies, and the evidence packages that facilitate constructive regulatory dialogue in any jurisdiction.
We provide the strategic guidance to get you from development to submission with confidence, whether the program involves a novel digital biomarker, a clinical outcome assessment qualification, or a SaMD regulatory pathway.
Frequently Asked Questions
What is the COA/DDT qualification pathway for digital endpoints?
The Clinical Outcome Assessment / Drug Development Tool qualification pathway allows sponsors to qualify a digital measurement tool for use across multiple drug development programs. This involves demonstrating reliability, validity, responsiveness, and clinical meaningfulness through a structured evidence package.
What is SaMD classification and how does it affect digital endpoints?
Software as a Medical Device (SaMD) classification determines the regulatory pathway for software-based clinical tools. Classification depends on the seriousness of the condition and the significance of the information the software provides.
How do regulatory requirements differ across global agencies?
Each agency has different evidentiary expectations, submission formats, and timelines. The FDA has DDT qualification and Breakthrough Device pathways. The EMA uses scientific advice and qualification procedures. Health Canada has jurisdiction-specific requirements.
What is a 510(k) predicate device strategy for digital motor assessment?
A 510(k) strategy identifies existing FDA-cleared devices that are substantially equivalent to your platform. For motor assessment, relevant predicates include Kinesia, StrivePD, and PKG. The strategy documents substantial equivalence in intended use, technological characteristics, and performance data.
When should sponsors engage regulatory strategy for digital endpoints?
Before Phase 1, to align endpoint selection with regulatory expectations from the start. Early engagement allows proactive dialogue through pre-submission meetings, Breakthrough Device designation, or EMA scientific advice. Correcting strategy mid-program costs years and tens of millions of dollars.
What We Deliver
Multi-Jurisdictional Strategy
Develop regulatory strategies that address FDA, EMA, and Health Canada requirements simultaneously. Identify jurisdiction-specific opportunities and challenges for efficient global submissions.
Regulatory Authority Engagement
Strategic planning for pre-submission meetings, breakthrough device designation applications, scientific advice procedures (EMA), and ongoing regulatory dialogue throughout development.
SaMD Classification & Pathway
Navigate software as a medical device classification across jurisdictions. Identify the appropriate regulatory pathway (510(k), de novo, CE marking) and build the technical documentation required for each.
COA / DDT Qualification
Develop the evidentiary package for Clinical Outcome Assessment and Drug Development Tool qualification. Navigate FDA Biomarker Qualification Program, EMA qualification pathways, and equivalent processes.
510(k) / De Novo Strategy
Predicate device analysis, substantial equivalence arguments, and de novo classification requests for digital motor assessment tools. Documented pathway with Kinesia, StrivePD, and PKG as predicates.
Regulatory Submission Support
Prepare endpoint-related sections of INDs, NDAs, BLAs, and device submissions with the depth and precision that regulatory reviewers expect in any jurisdiction.
Guidance & Precedent Analysis
Monitor and interpret evolving guidance on digital health, clinical outcome assessments, and CNS-specific regulatory expectations across global regulatory agencies.
Risk-Based Regulatory Planning
Identify regulatory risks early in development and build mitigation strategies into your program timeline before they become costly delays across multiple jurisdictions.
Typical Deliverables
Related Resources
Endpoint Consulting
Regulatory strategy starts with the right endpoints. See our approach to endpoint selection.
NeuroQuantix Platform
The COA/DDT qualification candidate built for regulatory submission from day one.
21 CFR Part 11 Compliance
21 CFR Part 11, HIPAA, CDISC, and GxP readiness that supports your regulatory pathway.
Assessed Conditions
Digital endpoints across 23 neurological conditions with published validation data.
Navigate the global regulatory landscape with clarity
Let us help you build a regulatory strategy that turns measurement innovation into regulatory acceptance, in every market that matters.
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