Hyman, Phelps & McNamara, P.C.

What Hyman, Phelps & McNamara, P.C. does

Hyman, Phelps & McNamara, P.C. (HPM) is a Washington, DC-based professional corporation founded in 1980 that operates as the largest dedicated boutique food and drug regulatory law firm in the United States, with a roster of 30+ lawyers. The firm provides legal counsel across the full FDA-regulated product lifecycle — premarket strategy and submissions (NDAs, BLAs, ANDAs, 510(k), PMA), cGMP and quality system compliance, enforcement defense and government investigations, healthcare fraud and abuse (anti-kickback, False Claims Act, Stark, Sunshine Act), controlled substances (DEA scheduling, import/export), Hatch-Waxman and biosimilars strategy, and transactional due diligence for M&A involving FDA-regulated entities. Its practice spans drugs, biologics, medical devices, combination products, foods, dietary supplements, cosmetics, tobacco/e-cigarettes, and agricultural products.

HPM's competitive position rests on concentrated regulatory expertise: attorneys routinely join from, or return to, the FDA Office of Chief Counsel, DOJ, DEA, HHS, and major pharmaceutical houses, and the firm's hiring criteria require prior government or in-house life sciences experience. The firm operates a category-defining thought leadership asset in the FDA Law Blog (thefdalawblog.com), supplemented by webinars, FDLI/DIA/IBA conference participation, and an "other law firm referral" channel where general-practice firms retain HPM for specialized matters.

HPM generates revenue through professional services fees — predominantly hourly billing on matters ranging from single-issue regulatory opinions to multi-year submission projects and enforcement defense. The client base spans startups through multinational corporations across all FDA-regulated verticals, with no public revenue disclosure. The firm is privately held by its directors and senior counsel, with no parent company, external investors, or acquisition history.

Name

Hyman, Phelps & McNamara, P.C.

Legal name

Hyman, Phelps & McNamara, P.C.

Website

https://hpm.com

Company type

Private

Founded year

1980

Operating status

Operating

Headcount range

51–100 employees

Short description

Hyman, Phelps & McNamara, P.C. is a Washington, DC-based FDA regulatory law firm founded in 1980, serving pharmaceutical, biotech, medical device, food, cosmetic, and tobacco clients with 30+ lawyers across the full product lifecycle.

Ownership category

akta.pro rank

Product category

FDA Regulatory Legal Services

NAICS

Legal Services (5411)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• FDA regulatory law
• Pharmaceutical legal services
• Medical device regulation
• Food and drug law
• Healthcare compliance

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations

Revenue model

1. Legal Services: Hyman, Phelps & McNamara generates revenue through providing legal services to FDA-regulated companies. Services include regulatory counsel, compliance advice, enforcement litigation, product development authorization, and due diligence for transactions.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Hyman, Phelps & McNamara, P.C. provides legal advice and representation concerning food, drug, medical device, cosmetic, controlled substance, and tobacco regulation, helping companies with FDA premarket submissions, ongoing compliance, enforcement defense, transactional due diligence, and healthcare fraud and abuse matters. The firm serves as outside regulatory counsel to pharmaceutical, biotech, medical device, food, dietary supplement, cosmetic, tobacco, and related life sciences companies across the full product lifecycle.

Product overview

Hyman, Phelps & McNamara, P.C. is a law firm specializing in FDA regulatory law, offering legal services rather than software products. The firm operates as a unified legal practice providing comprehensive regulatory counsel across multiple FDA-regulated industries including pharmaceuticals, biologics, medical devices, foods, dietary supplements, cosmetics, and tobacco. The firm offers specialized practice groups covering Compliance, Enforcement & Litigation, Product Development & Authorization, Due Diligence & Transactions, Healthcare, Manufacturing & Quality, and other regulatory areas. Their services range from premarket strategy and FDA submissions to government investigations, internal audits, and litigation defense.

Differentiator

Problem solved

Functional benefit

Products and services

• Compliance Legal Services Legal counsel on cGMP and quality system compliance matters, helping companies establish and maintain compliant manufacturing, storage, and distribution processes.
• Due Diligence & Transactions Legal Services Legal expertise for mergers, acquisitions, going public, and other business transactions as they relate to FDA, DEA, and USDA matters.
• Enforcement & Litigation Legal Services Legal representation in government investigations, enforcement actions, and litigation related to FDA and DEA regulations.
• Product Development & Authorization Legal Services Legal counsel guiding clients through FDA premarket submissions and product approval processes for drugs, biologics, and medical devices.
• Drugs & Biologics Regulatory Services Legal services covering new drug applications (NDAs, ANDAs), biologic license applications (BLAs), biosimilars, and regulatory strategy for pharmaceutical products.
• Medical Devices Regulatory Services Legal counsel for medical device development, 510(k) clearances, PMA approvals, IDE requirements, and post-market compliance.
• Foods & Dietary Supplements Regulatory Services Legal services for food products, dietary supplements, GRAS determinations, food additive petitions, and FSMA compliance.
• Controlled Substances Legal Services Legal counsel on DEA scheduling, import/export of controlled substances, quota issues, and compliance with federal and state controlled substance regulations.
• Cosmetics Regulatory Services Legal advice on cosmetics labeling, ingredient status, OTC drug monograph issues, establishment registration, and FTC advertising matters.
• Tobacco Products Regulatory Services Legal counsel on FDA tobacco product regulation, including e-cigarettes, traditional tobacco products, advertising restrictions, and warning labels.
• Retailer Compliance Services Legal counsel helping retailers develop policies and respond to FDA enforcement actions for dietary supplements, food, OTC drugs, and OTC devices.
• Agricultural Producers Legal Services Legal guidance on FDA and USDA regulations for agricultural producers, including FSMA compliance, food additive petitions, and organic labeling.
• Hatch-Waxman & Biosimilars Legal Services Legal services for abbreviated approval pathways including ANDA filings, patent certifications, biosimilar regulatory strategy, and Orange Book matters.
• Healthcare Fraud & Abuse Legal Services Legal counsel on anti-kickback statutes, False Claims Act, Stark Law, Sunshine Act compliance, and government pricing requirements.
• Manufacturing & Quality Legal Services Legal support for FDA inspection preparedness, response to Form 483 observations, Warning Letters, and quality system compliance.

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Market position

Competitive moat4 records

Key highlights6 records

Customer concentration

• Xtwitter.com/fdalawblog

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Hyman, Phelps & McNamara, P.C.