Senior Regulatory Strategy. Disciplined Execution. Trusted Under Scrutiny.
Regulatory Strategy & Execution for Complex and Emerging Technologies
A boutique regulatory affairs and data strategy firm guiding medical devices, diagnostics, pharmaceuticals, and combination products through U.S. and global regulatory pathways.
We partner with innovators from discovery through commercialization and post-market activities—delivering regulator-ready strategies grounded in real-world regulatory experience.
Built for regulator-ready strategy and documentation—minimizing rework, review cycles, and avoidable risk.
85+ submissions
Experience-backed outcomes and regulator-ready delivery.
90%+ approval success
Experience-backed outcomes and regulator-ready delivery.
18+ years avg senior experience
Experience-backed outcomes and regulator-ready delivery.
FDA & Global coverage
Experience-backed outcomes and regulator-ready delivery.
TRUSTED REGULATORY COVERAGE
FDA
Framework expertise
EU MDR
Framework expertise
IVDR
Framework expertise
ISO 13485
Framework expertise
ISO 14971
Framework expertise
IEC 62304
Framework expertise
Who We Are
Reg & Data AdGroup blends entrepreneurial agility with senior-level regulatory discipline to deliver focused, high-impact regulatory solutions.
Our team brings deep, hands-on experience across major FDA centers and divisions, supporting approvals across diverse therapeutic areas and global markets. We have partnered with more than 150 companies—from early-stage startups to mid-sized organizations and large global enterprises—providing trusted regulatory leadership at every stage of development.
From discovery through commercialization and post-market activities, clients rely on us to deliver maximum value through close cross-functional collaboration, disciplined execution, and practical regulatory judgment grounded in real-world experience.
Our integrated service model spans regulatory strategy, submissions and lifecycle management, clinical and analytical evidence strategy, AI/ML and SaMD regulatory support, and quality and compliance—allowing us to tailor solutions to each product’s scientific complexity, technical risk, and stage of development.
SERVICES
Regulatory support across the full product lifecycle
An integrated model spanning strategy, submissions, lifecycle management, evidence generation, AI/ML SaMD support, and quality/compliance.
SELECTED OUTCOMES
High-impact support across complex programs
Examples are anonymized and representative of how clients use our services.
510(k) Strategy + Submission Execution
End-to-end pathway planning, predicate strategy, and submission-ready documentation with disciplined timelines and consistent narratives.
Outcome
Reduced rework and accelerated review cycle confidence.
EU MDR / IVDR Technical Documentation
Technical documentation strategy aligned to clinical/performance expectations, risk, and labeling with regulator-ready consistency.
Outcome
Improved audit readiness and defensibility under scrutiny.
AI/ML SaMD Validation + PCCP Support
Model validation documentation, bias/generalizability analyses, and change control planning aligned to intended use and lifecycle monitoring.
Outcome
Stronger evidence story for modern review expectations.
NEXT STEP
Move forward with regulator-ready clarity
Book a 30-minute complimentary consultation to discuss product type, pathway, evidence expectations, and a practical plan for timelines and execution.
Typical response time: same business day.
Who We Serve
Startups, mid-sized companies, and global enterprises
Medical devices (Class I–III), IVDs and diagnostics
SaMD, digital health, AI/ML-enabled technologies
Combination products and pharmaceuticals
Support across the full product lifecycle—from early ideation to post-market
ENGAGEMENT MODELS
How Clients Use Our Services
Project-based engagements for defined regulatory needs
Embedded or fractional regulatory leadership
Strategic advisory support for complex or high-risk programs
Why Choose Us
Senior expertise, disciplined execution, and evidence-backed decisions—without enterprise overhead.
OUR COMMITMENT
We take ownership of our work. We hold ourselves accountable to quality, discipline, and delivery. Our success is measured by our clients’ ability to move confidently through regulatory review and achieve sustainable approvals.
FAQ
Common questions
Clear answers to accelerate decision-making.
Product description and intended use, current development stage, target markets (U.S./EU/global), any prior regulatory interactions, and available evidence (clinical/analytical/software validation).
Yes. We support U.S. FDA pathways (510(k), De Novo, PMA, Pre-Subs/Q-Subs) and EU MDR/IVDR strategies and technical documentation, including clinical/performance evaluation support.
Both. Clients use us for defined projects (e.g., submissions, responses, gap assessments) or embedded/fractional regulatory leadership to drive cross-functional execution and governance.
Yes. We support AI/ML SaMD classification and strategy, model validation documentation, bias/generalizability analyses, and Predetermined Change Control Plan (PCCP) strategy and lifecycle monitoring.
We can typically start quickly depending on scope and urgency. We’ll confirm timelines and milestones during the initial discussion and lock an execution plan once scope is defined.
Our Core Values
Regulatory Integrity
What it means: Uncompromising ethics, scientific rigor, and regulatory honesty.
What clients get: Trustworthy strategies that stand up to FDA and global regulator scrutiny.
Quality First
What it means: Regulator-ready work from day one—no shortcuts, no rework.
What clients get: Fewer questions, faster reviews, and higher-confidence approvals.
Ownership & Accountability
What it means: We own outcomes, not just deliverables.
What clients get: Clear timelines, proactive risk management, and no surprises.
Speed with Discipline
What it means: Startup agility guided by experienced regulatory judgment.
What clients get: Faster progress without compliance risk.
True Partnership & Collaboration
What it means: We roll up our sleeves and work alongside your team.
What clients get: Faster decisions, pragmatic solutions, and a partner invested in your success.
CONTACT
Let’s Get in Touch — 30-Minute Complimentary Consultation
Tell us a bit about your product and regulatory goals. We’ll respond quickly with clear next steps.
Send a message
Share product type, region, timeline, and what you need. We’ll follow up fast.
Locations
San Diego, CA
Serving clients globally
Morrisville, NC
Serving clients globally
Las Vegas, NV
Serving clients globally
WHAT TO EXPECT
- Senior-led review of product type, pathway, evidence, and risk.
- Clear next steps with timeline discipline and regulator-ready deliverables.
- A right-sized engagement model (project-based, embedded, or advisory).