FDA Regulatory Experts
FDA Regulatory Experts (One Way Consultants, LLC) is an independent consulting firm providing FDA regulatory, quality systems, and clinical study services to Class I-III medical device manufacturers, led by Principal Consultant Larry Stevens and supported by vetted partner consultants.
- Company typePrivate
- Founded2011
- HeadquartersEast Alton, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What FDA Regulatory Experts does
FDA Regulatory Experts, doing business as One Way Consultants, LLC, is an independent FDA regulatory consulting firm founded in 2011 and based in Rosewood Heights, Illinois. The firm specializes in regulatory affairs, quality systems, and clinical study support for medical device manufacturers across Class I, II, and III devices, with service offerings spanning mock FDA inspections, FDA-483 and Warning Letter responses, 510(k) Premarket Notifications, IDE, De Novo, and PMA submissions, GMP and design control (21 CFR Part 820.30) training and audits, clinical study design and management, FDA pre-submission meeting preparation, CAPA program evaluation, and expert witness testimony.
The firm's delivery model is principal-consultant led: Larry Stevens, who combines 20+ years of FDA experience with 18 years as a medical device industry senior executive, personally leads engagements and draws on a screened network of independent quality and regulatory consultants (specializing in FDAAA, QA/QC, and QR) for capacity overflow. This positioning, supported by Stevens' prior service on the FDA Circulatory Systems panel (1989-1993) and 250+ public presentations, is the firm's central differentiator against larger regulatory consultancies.
The business model is professional services on a quote-based, hourly or per-project billing structure, with a free initial consultation and a public guarantee of "FDA success." Go-to-market is sales-led and community-led: direct phone/email outreach supplemented by an educational blog ("FDA and Devices"), regular webinars, an active LinkedIn presence, and word-of-mouth referrals within the medical device and legal communities. The firm holds no external investment, has no patents or awards, and operates exclusively within the United States.
FDA Regulatory Experts firmographics
Firmographics- Name
- FDA Regulatory Experts
- Legal name
- One Way Consultants, LLC
- Website
- https://fdadeviceexpert.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- FDA Regulatory Experts (One Way Consultants, LLC) is an independent consulting firm providing FDA regulatory, quality systems, and clinical study services to Class I-III medical device manufacturers, led by Principal Consultant Larry Stevens and supported by vetted partner consultants.
- Ownership category
- akta.pro rank
FDA Regulatory Experts industry classification
Industry- Product category
- Regulatory Affairs Consulting
- NAICS
- Management, Scientific, and Technical Consulting Services (5416)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)
- akta.pro secondary industry
- Medical Device Regulators (HLAJADAC)
Keywords
Where FDA Regulatory Experts is headquartered
LocationHeadquarters
- HQ city
- East Alton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
FDA Regulatory Experts business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Marketing or Sales, Operations, Others
Revenue model
- Regulatory Consulting Services: Professional consulting services for FDA regulatory compliance, including mock FDA inspections, FDA-483 responses, Warning Letter responses, 510(k) submissions, IDE, PMA applications, design controls, and clinical trial management. Billed hourly or by project engagement.
- Expert Witness Services: Serves as expert witness for cases involving FDA regulation compliance for medical devices.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Other | Free initial consultation |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
FDA Regulatory Experts product offering
Product offeringCore offering
FDA Regulatory Experts, operated by One Way Consultants LLC, provides specialized FDA regulatory consulting services for medical device companies. The firm delivers quality systems services (mock inspections, FDA-483 and Warning Letter responses), regulatory submission services (510(k), IDE, De Novo, PMA), FDA compliance training programs, design control consulting per 21 CFR Part 820.30, and clinical study design and management. Expert witness services for FDA-related litigation are also offered.
Product overview
FDA Regulatory Experts, operated by One Way Consultants LLC, is a consulting advisory firm providing specialized FDA regulatory consulting services for the medical device industry. The company offers a comprehensive suite of regulatory affairs, quality assurance, and compliance services organized into five primary service categories: (1) Quality Systems services including mock FDA inspections, FDA-483 and Warning Letter responses; (2) Regulatory Submissions services covering 510(k), IDE, De Novo, and PMA applications; (3) FDA Training programs including GMP, regulatory submissions, internal auditor, labeling/advertising, and train-the-trainer; (4) Design Control services per 21 CFR Part 820.30; (5) Clinical Study Design and Management services; and (6) FDA Pre-Submission Meeting support. Additional offerings include expert witness services and CAPA program evaluation. The firm does not offer a software platform or technology product—it delivers professional consulting services through expert personnel.
Differentiator
Problem solved
Functional benefit
Products and services
- Mock FDA Inspections Pre-inspection readiness assessments that simulate FDA facility audits to identify compliance gaps before actual regulatory inspections occur. For medical device manufacturers.
- FDA-483 Responses Expert assistance in preparing and formulating responses to FDA Form 483 observations issued during regulatory inspections. For medical device manufacturers.
- FDA Warning Letter Responses Strategic planning and response development for FDA Warning Letters, including corrective action plans and remediation strategies. For medical device manufacturers.
- 510(k) Premarket Notification Preparation and submission of 510(k) premarket notifications to FDA demonstrating substantial equivalence for Class I, II, and certain Class III medical devices. For medical device manufacturers.
- IDE - Investigational Device Exemption Regulatory submission services for Investigational Device Exemption applications required to conduct clinical trials on unapproved devices. For medical device manufacturers.
- De Novo Application Preparation and submission of De Novo requests for novel medical devices without a predicate that require a new classification category. For medical device manufacturers.
- Premarket Approval Application (PMA) Comprehensive PMA preparation and submission services for Class III medical devices requiring FDA approval based on safety and effectiveness data. For medical device manufacturers.
- GMP Training Good Manufacturing Practice training programs covering FDA quality system requirements under 21 CFR Part 820. For medical device manufacturer personnel.
- Regulatory Submissions Training Professional development training on FDA regulatory submission processes, documentation requirements, and strategic planning. For medical device regulatory personnel.
- Internal Auditor Training Training programs for internal quality auditors to conduct effective quality system audits per FDA requirements. For medical device quality personnel.
- FDA Labeling and Advertising Training Training on FDA labeling requirements, promotional claims, and advertising compliance for medical devices. For medical device marketing and regulatory staff.
- Train the Trainers Program Comprehensive train-the-trainer program enabling organizations to develop internal FDA compliance training capabilities. For medical device manufacturers.
- Design Control Consulting (21 CFR Part 820.30) Assistance in establishing and maintaining design control procedures per FDA requirements, including design input, output, verification, validation, and design review. For medical device manufacturers.
- Mock FDA Design Control Audit Simulated FDA design control audits to assess compliance with 21 CFR Part 820.30 requirements. For medical device manufacturers.
- Clinical Study Design and Management Comprehensive clinical trial services including establishing endpoints, creating protocols, informed consent documents, IRB approval, and FDA IDE submissions. For medical device manufacturers.
- FDA Pre-Submission Meeting Support Arrangement and management of FDA pre-submission meetings including contact, meeting request preparation, and meeting conduct services. For medical device manufacturers.
- Expert Witness Services Expert witness services for legal cases involving FDA regulation compliance for medical devices. For attorneys and law firms.
- CAPA Program Evaluation Assessment of Corrective and Preventive Action programs to ensure effectiveness and FDA compliance. For medical device manufacturers.
- FDA Strategic Plans Development of strategic regulatory plans for startup companies navigating FDA approval pathways. For medical device startups and manufacturers.
Quantifiable outcome
- Guaranteed FDA success or problems solved
Companies that use FDA Regulatory Experts
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
FDA Regulatory Experts technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
FDA Regulatory Experts partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Independent Quality and Regulatory ConsultantsminorThe company partners with independent quality and regulatory experts who have been screened and vetted. Partners are described as qualified and successful consultants. The partner network includes specialists in FDAAA, QA/QC, and QR areas. However, specific partner company names are not disclosed on the website.
Scale indicators4 records
Recent moves4 records
Expansion highlights4 records
FDA Regulatory Experts competitors and assessment
Company assessmentDirect peers
- Innolitics: Medical device software and regulatory consulting firm supporting FDA submissions, cybersecurity, and SaMD compliance. Comparable as a niche, expertise-led regulatory consultancy for medical device software developers.
- StarFish Medical: Medical device product development and regulatory consulting firm with FDA submission expertise. Comparable in supporting medtech innovators through design controls, clinical, and regulatory pathways.
- ProPharma Group: Life sciences consulting firm providing regulatory affairs, pharmacovigilance, and compliance services to pharma and medical device companies. Comparable in service lines (regulatory submissions, quality systems) and target customer profile.
- Celegence: Regulatory affairs and compliance consulting firm supporting medical device and pharmaceutical companies with submissions, gap analyses, and remediation. Comparable boutique peer in regulatory services for regulated life sciences clients.
- The FDA Group: Specialized FDA regulatory and quality consulting firm serving pharmaceutical and medical device manufacturers with inspection readiness, submissions, and remediation support. Most directly comparable boutique peer to FDA Regulatory Experts in scope and target client profile.
Broad incumbents
- NAMSA: Large medical device-focused CRO offering regulatory, clinical, and laboratory testing services across the full product lifecycle. Comparable as a full-service regulatory/quality partner to medical device manufacturers, though at materially larger scale.
- IQVIA: Global CRO and life sciences consulting firm with broad regulatory affairs and clinical capabilities. Overlaps with FDA Regulatory Experts' regulatory submission and clinical study services, but at very different scale and geographic reach.
Emerging players
- Greenlight Guru: Medical device quality management system (QMS) software platform with adjacent consulting and training services. Comparable at the intersection of regulatory/quality enablement for medtech, though it sells a software platform rather than pure consulting.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
FDA Regulatory Experts social profiles
Digital presenceFDA Regulatory Experts financial estimates
Financial estimateRevenue estimate
Valuation estimate
FDA Regulatory Experts leadership team
Management profileNumber of profiles
Profiles1 record
FDA Regulatory Experts funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
FDA Regulatory Experts M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about FDA Regulatory Experts
What does FDA Regulatory Experts do?
FDA Regulatory Experts, operated by One Way Consultants LLC, provides specialized FDA regulatory consulting services for medical device companies. The firm delivers quality systems services (mock inspections, FDA-483 and Warning Letter responses), regulatory submission services (510(k), IDE, De Novo, PMA), FDA compliance training programs, design control consulting per 21 CFR Part 820.30, and clinical study design and management. Expert witness services for FDA-related litigation are also offered.
Is FDA Regulatory Experts a public or private company?
FDA Regulatory Experts is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was FDA Regulatory Experts founded?
FDA Regulatory Experts was founded in 2011. It employs 1 to 10 people.
Where is FDA Regulatory Experts based?
FDA Regulatory Experts is headquartered in East Alton, United States, in the North America region.
How does FDA Regulatory Experts make money?
Two revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are expert Witness Services.
Who are FDA Regulatory Experts's main competitors?
Direct peers on record are Innolitics, StarFish Medical, ProPharma Group, Celegence and The FDA Group. Broad incumbents are NAMSA and IQVIA. Greenlight Guru is listed as an emerging player.
Does FDA Regulatory Experts have an API?
No public API is recorded for FDA Regulatory Experts.
What industry is FDA Regulatory Experts in?
FDA Regulatory Experts's product category is Regulatory Affairs Consulting. Its primary akta.pro industry code is HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management), with a secondary code of HLAJADAC, Medical Device Regulators. Its NAICS code is 5416 and its SIC code is 8731.