McKinney Regulatory Science Advisors

What McKinney Regulatory Science Advisors does

McKinney Regulatory Science Advisors, LLC is a Virginia-based regulatory science consultancy that advises nicotine and cannabis manufacturers on achieving and maintaining FDA and global regulatory compliance. The firm was founded by Dr. Willie McKinney, Ph.D., DABT — a veteran tobacco and nicotine executive who previously served as the industry representative on the FDA Tobacco Products Scientific Advisory Committee — and is supported by a team of toxicologists, chemists, behavioral scientists, and research professionals whose combined domain experience exceeds 200 years. The company holds Small, Minority-Owned Business (SMBE) certification through the State of Virginia, obtained in July 2024.

The firm's service portfolio is organized into two practice areas. The Nicotine practice covers regulatory consultancy, product assessment and testing (nonclinical, clinical, chemical, and behavioral studies), Premarket Tobacco Product Application (PMTA) preparation and submission, global applications (EU TPD, UK TRPR, MHRA, TGA), and post-market compliance support. The Cannabis practice applies lessons from the nicotine regulatory track record to inhalable, combustible, oil-based, and ingestible products, covering regulatory consultancy, product testing, stakeholder engagement, quality and compliance, and specialized analyses of cannabinoids and terpenes/flavonoids. Notable proprietary capabilities include PMTA narrative development that frames products as appropriate for the protection of public health (APPH), bespoke regulatory strategy development, and non-targeted chemical analysis delivered through specialized laboratory partners.

The business operates on a professional services model with engagements typically structured as projects or retainers; PMTA engagements are described as significant seven-to-eight-figure investments spread over multiple years. Go-to-market is sales-led and direct: prospective clients engage via the company website contact form, email (info@mckinneyrsa.com), phone ((804) 461-3208), or in-person meetings at industry conferences. The firm is privately held, has no disclosed external funding, no parent company, and no disclosed headcount, with named team members including the Founder/CEO, a behavioral science Advisor (Sc.D., M.P.H.), and a Chief Scientific Officer who also directs a UK-based consulting firm.

Name

McKinney Regulatory Science Advisors

Legal name

McKinney Regulatory Science Advisors, LLC

Website

https://mckinneyrsa.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

McKinney Regulatory Science Advisors is a Virginia-based boutique regulatory science consultancy that helps nicotine and cannabis manufacturers navigate FDA PMTA submissions, product testing, and post-market compliance, leveraging a team with over 200 years of combined domain experience and FDA advisory standing.

Ownership category

akta.pro rank

Product category

Regulatory Consulting Services

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Services (8741)

akta.pro industry

PRIMARYBPAHAFAB

Regulatory Compliance Advisory

Business & Public Services/Professional Services (Legal, Accounting, Consulting)/Risk, Compliance & Governance Advisory

SECONDARYAFALADAC

Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA)

Agriculture & Food Production/Food Safety, Testing & Certification/Regulatory Compliance Testing & Consulting (FDA/USDA/EFSA, HACCP)

Keywords

• Regulatory science consulting
• Nicotine product compliance
• Cannabis regulatory advisory
• PMTA submission services
• FDA regulatory strategy

Headquarters

HQ city

Henrico

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Regulatory Consultancy Services: Professional consulting fees for regulatory strategy, product testing oversight, submission preparation, and post-market compliance support for nicotine and cannabis manufacturers. Services are tailored to client needs and typically billed on a project or retainer basis.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

McKinney RSA is a regulatory science consultancy that guides nicotine and cannabis manufacturers through FDA and global regulatory pathways. Core offerings include PMTA strategy and submission services, product testing program design and oversight, regulatory submissions across multiple jurisdictions, post-market compliance support, and stakeholder engagement for both nicotine and cannabis product categories.

Product overview

McKinney Regulatory Science Advisors operates as a regulatory science consultancy, not a software product company. They offer a unified portfolio of advisory and consulting services organized into two main practice areas: Nicotine Regulatory Services (including Regulatory Consultancy, Product Testing, PMTA Applications & Submissions, Global Applications, and Post-Market Compliance Support) and Cannabis Regulatory Services (including Regulatory Consultancy, Product Testing, Stakeholder Engagement, Quality and Compliance, Cannabinoids Analysis, and Terpenes & Flavonoids Analysis). These services are delivered through expert consultation rather than software products or platforms.

Differentiator

Problem solved

Functional benefit

Products and services

• Nicotine Regulatory Consultancy Comprehensive regulatory consultancy services guiding tobacco and nicotine manufacturers through FDA and global regulatory challenges, including PMTA strategy, preparation, submission, and post-market compliance.
• Nicotine Product Testing Services Design and execution of product assessment and testing programs including nonclinical studies, clinical studies, chemical characterization, risk assessment, and behavioral studies to streamline approval and market access for nicotine products.
• PMTA Application and Submission Services Premarket Tobacco Product Application (PMTA) preparation and filing services, including regulatory assessment, strategy development, application management, and post-submission support for FDA marketing orders.
• Global Applications & Submissions Regulatory pathway navigation for global markets including the EU Tobacco Products Directive (TPD), UK TRPR, and medical applications to MHRA (UK) and TGA (Australia).
• Post-Market Compliance Support Ongoing compliance solutions including gap analysis, submission strategy, policy development, and regulatory risk management following FDA marketing decisions.
• Cannabis Regulatory Consultancy Regulatory consultancy applying lessons from the nicotine industry to help cannabis manufacturers understand toxicological and societal implications, evaluate products with a regulatory lens, and navigate state-by-state filings.
• Cannabis Product Testing Services Product assessment and testing programs for cannabis including efficiency optimization, tailored studies, and results interpretation covering chemical analysis, nonclinical and clinical evaluation.
• Stakeholder Engagement Services Managing business reputation and regulatory risk through proactive compliance assessments, regulatory relations, quality assurance, and compliance remediation support for cannabis clients.
• Quality and Compliance Services (Cannabis) Navigation of regional regulatory requirements covering licensing, cultivation, manufacturing, packaging, labeling, and ongoing compliance including renewal management for cannabis operations.
• Cannabinoids Analysis Services Analysis of THC to CBD ratios and terpene interactions to help manufacturers achieve intended product effects without causing harm, including regulatory planning and laboratory evaluation.
• Terpenes & Flavonoids Analysis Services Ingredient and material risk assessment for terpenes and flavonoids, including initial evaluation, hazard detailing, tiered testing, and real-time decision-making guardrails.

Quantifiable outcome

• 74% of PMTA applications submitted to FDA were refused acceptance; only 31 marketing orders granted out of millions of products submitted — McKinney RSA helps manufacturers avoid these outcomes through expert guidance.

Named customers3 records

Segments2 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Abstrax Tech Inc.coreStrategic or Co-development PartnerMcKinney RSA and Abstrax are collaborating on a comprehensive toxicological risk assessment program for Abstrax's botanically derived and cannabis-inspired terpenes. The partnership also aims to develop a regulatory framework that governing bodies can adopt and manufacturers can use to create safer products. McKinney RSA provides regulatory, chemistry, toxicology, clinical behavioral science, and project management expertise.
• Trait Bioscience Inc.coreStrategic or Co-development PartnerTrait Bioscience commissioned McKinney RSA's services in 2022 for regulatory landscape research, toxicology, chemistry, and clinical testing guidance related to Trait's cannabis/bioscience research programs, including future collaborative research.
• Bonguard NaturalscoreStrategic or Co-development PartnerMcKinney RSA developed and executed a scientific evaluation program for Bonguard Naturals' Nixodine-S (S)-6-methylnicotine bulk ingredient. The program included acute toxicity testing relative to nicotine, evaluation of nAChR activation potential, and guidance on testing considerations for finished products containing nicotine analogs.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Eurofins Scientific: Large global laboratory services provider with extensive food, cannabis, and pharmaceutical testing capabilities. Provides the non-targeted chemical analysis and laboratory testing services that McKinney RSA partners with or competes against.
• Exponent: Large scientific and engineering consulting firm with significant practice in FDA-regulated product regulatory science, toxicology, and risk assessment. Competes for high-value regulatory consulting work but operates across many industries beyond nicotine/cannabis.
• Keller and Heckman: Law firm with a deep FDA regulatory practice covering tobacco, food, drugs, and consumer products. Actively participates in PMTA-related events and panels, making it a competitor for regulatory advisory work alongside McKinney RSA.
• Intertek: Global testing, inspection, and certification firm with a Consumer Goods practice covering tobacco, e-cigarettes, and cannabis product testing. Competes for the analytical chemistry and product testing portions of McKinney RSA's offerings.

Emerging players

• Broughton: Scientific and regulatory consultancy serving the tobacco, nicotine, and e-cigarette industries with toxicology, regulatory, and product stewardship services. Direct competitor in PMTA-related testing and regulatory strategy work.
• Cannabis Safety First: Regulatory and compliance consulting firm focused exclusively on cannabis quality assurance, safety testing, and regulatory strategy. Comparable in cannabis-specific regulatory advisory positioning.
• Labstat International: Specialized contract research organization focused on tobacco and nicotine product testing, analytical chemistry, and toxicological assessments. Comparable for the product testing service element of McKinney RSA's portfolio.
• Vicarius Regulatory Solutions: Regulatory affairs and quality assurance consultancy serving FDA-regulated industries including cannabis, tobacco, and consumer products. Comparable scope for cannabis regulatory compliance and quality systems work.

Direct peers

• Pinney Associates: Consulting firm specializing in tobacco harm reduction, nicotine regulatory science, and behavioral research. Direct competitor in the nicotine/tobacco regulatory advisory space, with similar strategic focus on reduced-risk products and FDA submissions.
• EAS Consulting Group: FDA regulatory and scientific consulting firm providing expertise in product development, regulatory submissions, and compliance across food, dietary supplements, cosmetics, and tobacco/nicotine categories. Directly competes for FDA regulatory consulting engagements.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/mckinney_rsa
• YouTubeyoutube.com/@McKinneyRSA/featured
• LinkedInlinkedin.com/company/mckinney-regulatory-science-advisors-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about McKinney Regulatory Science Advisors