Dunn Regulatory Associates
Dunn Regulatory Associates (DRA) is a Vienna, Virginia-based regulatory and scientific consulting firm serving pharmaceutical, biotech, and medical device companies globally with FDA and EMA strategy, eCTD submissions, medical writing, and US Agent services; operating as a subsidiary of Acacium Group.
- Company typePrivate
- Founded2014
- HeadquartersOakton, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Dunn Regulatory Associates does
Dunn Regulatory Associates, LLC (DRA) is a privately held regulatory and scientific consulting firm founded in 2014 and headquartered in Vienna, Virginia, within the Washington, D.C. metropolitan area. The firm serves pharmaceutical, biotechnology, and medical device companies globally, providing expert regulatory strategy and execution across pre-IND through post-marketing product lifecycle. DRA's service portfolio spans eight integrated offerings: Nonclinical Consulting, Clinical Consulting, CMC Regulatory Strategy, GxP Compliance Services, Regulatory Strategy, Medical Writing, Regulatory Operations, and US Agent Services. Its client base includes Rx and OTC pharmaceutical sponsors, biotech developers of complex biologics (including cell therapy, gene therapy, monoclonal antibodies, antibody-drug conjugates, and vaccines), medical device manufacturers (including drug-device combinations and digital therapeutics), and non-U.S. firms requiring a designated U.S. Agent for FDA interactions.
The firm's operational backbone is conventional regulatory technology rather than proprietary software: electronic publishing and lifecycle management of eCTD submissions via the FDA's Electronic Submission Gateway (ESG), with quality-controlled document preparation across all CTD modules. Service delivery is led by senior regulatory strategists with PhD-level scientific credentials and direct experience negotiating with FDA and EMA, including expertise in expedited pathways (Breakthrough Therapy, Fast Track, Orphan Drug). Customer engagement is direct, project-based or retainer-driven, with pricing quoted against scope and not publicly disclosed. Geographic reach is achieved through a U.S. headquarters in Vienna, VA and a European regional operation (DRA EU) established in September 2022 to support EMA and MHRA interactions.
DRA has been a wholly owned subsidiary of Acacium Group, a global life sciences and healthcare solutions partner, since its acquisition on March 24, 2021. The acquisition positioned DRA as the regulatory consulting arm within Acacium's international life sciences division, providing access to broader group resources and international reach while preserving the firm's independent operating identity and senior leadership under founder Dana Dunn. Firm-reported employee count is 1-10, indicating a lean expert-consultant operating model with likely reliance on contract specialists to scale delivery.
Dunn Regulatory Associates firmographics
Firmographics- Name
- Dunn Regulatory Associates
- Legal name
- Dunn Regulatory Associates, LLC
- Website
- https://dunnregulatory.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Dunn Regulatory Associates (DRA) is a Vienna, Virginia-based regulatory and scientific consulting firm serving pharmaceutical, biotech, and medical device companies globally with FDA and EMA strategy, eCTD submissions, medical writing, and US Agent services; operating as a subsidiary of Acacium Group.
- Ownership category
- akta.pro rank
Dunn Regulatory Associates industry classification
Industry- Product category
- Pharmaceutical Regulatory Consulting
- NAICS
- Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Health Services (8000)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industries
- Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
Keywords
Where Dunn Regulatory Associates is headquartered
LocationHeadquarters
- HQ city
- Oakton
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Dunn Regulatory Associates business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Regulatory Consulting Services: Professional consulting services provided to pharmaceutical, biotech, and medical device companies for regulatory strategy, submissions, compliance, and product development support. Services are typically project-based or retainer arrangements for ongoing regulatory support.
- US Agent Services: Acting as US representative for non-US firms seeking entry into the US pharmaceutical market, providing regulatory submissions gap analysis, FDA communications, and meeting participation services.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels2 records
Dunn Regulatory Associates product offering
Product offeringCore offering
Dunn Regulatory Associates (DRA) is a regulatory and scientific consulting firm that supports pharmaceutical, biotechnology, and medical device companies with regulatory strategy, FDA and EMA submissions, eCTD publishing, nonclinical/clinical/CMC consulting, GxP compliance, medical writing, and US Agent representation for non-US firms. Services span the full product lifecycle from pre-IND through post-marketing, delivered by senior regulatory strategists operating from offices in the US (Virginia) and Europe (DRA EU).
Product overview
Dunn Regulatory Associates is a regulatory consulting firm offering integrated regulatory and scientific consulting services to the global healthcare industry. The portfolio comprises distinct service offerings across pharmaceuticals, biologics, and medical devices, encompassing Nonclinical Consulting, Clinical Consulting, CMC Regulatory Strategy, GxP Compliance Services, Regulatory Strategy, Medical Writing, Regulatory Operations, and US Agent Services. These services are designed to streamline product development from discovery through market authorization, supporting Rx and OTC pharmaceuticals, biopharmaceuticals, and devices using an experience-based approach that integrates scientific expertise, business acumen, and regulatory strategy.
Differentiator
Problem solved
Functional benefit
Products and services
- Pharmaceuticals Regulatory Consulting
Companies that use Dunn Regulatory Associates
Customer profileSegments4 records
Ideal customer profiles4 records
Dunn Regulatory Associates technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Dunn Regulatory Associates partnerships and signals
Strategic signalScale indicators1 record
Recent moves5 records
Expansion highlights5 records
Dunn Regulatory Associates competitors and assessment
Company assessmentBroad incumbents
- PharmaLex (Cencora): PharmaLex, now part of Cencora/World Courier, is a global regulatory affairs and development consulting firm — a broader incumbent offering regulatory strategy, submissions, and pharmacovigilance comparable to DRA's services.
- IQVIA: IQVIA is a global CRO and life sciences services giant offering integrated regulatory, clinical, and consulting services at massive scale — relevant as a broader competitor and employer of DRA alumni, but much larger and broader in scope.
- Parexel International: Parexel is a top-tier global CRO offering regulatory consulting, clinical development, and biopharmaceutical services — a broader incumbent competing with DRA for mid-cap pharma/biotech regulatory engagements.
Regional players
- Arriello: Arriello is a European-based regulatory affairs and drug development consultancy serving pharma and biotech across EU and US markets — comparable to DRA EU as a regional regulatory consulting peer with similar cross-Atlantic capabilities.
Direct peers
- Voisin Consulting Life Sciences: Voisin Consulting provides regulatory strategy, clinical development, and health economics consulting across pharma, biotech, and devices — directly comparable to DRA's cross-modality regulatory consulting offering.
- ProPharma Group: ProPharma Group is a privately-held regulatory, compliance, and consulting firm serving pharma, biotech, and medical device companies globally — a direct head-to-head comparable to DRA in regulatory consulting, medical writing, and GxP compliance services.
- BlueReg Consulting: BlueReg is a regulatory affairs consultancy providing global submission strategy, regulatory writing, and US Agent/EMA representation for pharma and biotech — directly comparable to DRA's US Agent service and EU/US regulatory capabilities.
- NDA Group: NDA Group is a regulatory and HTA consulting firm supporting pharma and biotech clients with global submission strategy, regulatory affairs, and CMC — comparable to DRA in regulatory strategy, medical writing, and CMC services.
- Camargo Pharmaceutical Services: Camargo is a specialized regulatory consulting firm focused on 505(b)(2) NDA development, due diligence, and global regulatory strategy for pharma — closely comparable to DRA's pharmaceutical regulatory consulting and strategy practice.
- Regulatory Compliance Associates (RCA): RCA is a life sciences consulting firm specializing in FDA/EMA regulatory compliance, quality systems, and GxP auditing for pharma and medical device manufacturers — comparable to DRA's GxP compliance and regulatory strategy services.
Market position
Strengths1 record
Weaknesses1 record
Competitive moat3 records
Key risks5 records
Key highlights5 records
Customer concentration
Dunn Regulatory Associates social profiles
Digital presenceDunn Regulatory Associates financial estimates
Financial estimateRevenue estimate
Valuation estimate
Dunn Regulatory Associates leadership team
Management profileNumber of profiles
Profiles14 records
Dunn Regulatory Associates subsidiaries and ownership
Company hierarchySubsidiaries1 record
Dunn Regulatory Associates funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Dunn Regulatory Associates 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 Dunn Regulatory Associates
What does Dunn Regulatory Associates do?
Dunn Regulatory Associates (DRA) is a regulatory and scientific consulting firm that supports pharmaceutical, biotechnology, and medical device companies with regulatory strategy, FDA and EMA submissions, eCTD publishing, nonclinical/clinical/CMC consulting, GxP compliance, medical writing, and US Agent representation for non-US firms. Services span the full product lifecycle from pre-IND through post-marketing, delivered by senior regulatory strategists operating from offices in the US (Virginia) and Europe (DRA EU).
Is Dunn Regulatory Associates a public or private company?
Dunn Regulatory Associates is a private company. It is classified as corporate owned and is currently operating.
When was Dunn Regulatory Associates founded?
Dunn Regulatory Associates was founded in 2014. It employs 1 to 10 people.
Where is Dunn Regulatory Associates based?
Dunn Regulatory Associates is headquartered in Oakton, United States, in the North America region.
How does Dunn Regulatory Associates make money?
Two revenue lines are on record. Regulatory Consulting Services are the primary driver. The others are US Agent Services.
Who are Dunn Regulatory Associates's main competitors?
Broad incumbents on record are PharmaLex (Cencora), IQVIA and Parexel International. Arriello is listed as a regional player. Direct peers are Voisin Consulting Life Sciences, ProPharma Group, BlueReg Consulting, NDA Group, Camargo Pharmaceutical Services and Regulatory Compliance Associates (RCA).
Does Dunn Regulatory Associates have an API?
No public API is recorded for Dunn Regulatory Associates.
What industry is Dunn Regulatory Associates in?
Dunn Regulatory Associates's product category is Pharmaceutical Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGAKAC, Regulatory Operations & Publishing (eCTD, RIM, Submission Management). Its NAICS code is 54161 and its SIC code is 8731.