Arkin Consulting Group

What Arkin Consulting Group does

Arkin Consulting Group (ACG) is a privately held professional services firm founded in 1994 and domiciled in Canton, Georgia, that provides FDA and ISO regulatory, quality assurance, and clinical management consulting to medical device, pharmaceutical, biologics, and veterinary product companies. The firm operates five integrated service lines: quality assurance and compliance (audits, ISO 13485 certification, CE-Mark, quality systems development), strategic regulatory consulting and submissions (PMA, 510(k), NDA, IND, IDE/HDE, FDA-483 and warning letter responses), clinical planning, management and monitoring (Phase I-IV trial design, biostatistics, FDA inspection readiness), international experience services (ISO 9001/13485 certification, FDA U.S. Agent services for non-U.S. companies, European and Asian market documentation), and validation consulting (process and software validation, IQ/OQ/PQ, V&V packages).

ACG monetizes exclusively through professional services engagements priced on a quote basis, with multi-year contract cadence typical for ongoing regulatory programs. The go-to-market is sales-led and relationship-driven: senior practitioners are directly involved in every account, with new client dialogue initiated via phone, email, or the website contact form. The firm explicitly focuses on small to medium-sized firms alongside select multi-national corporations, including start-up biotechs seeking international market launches. Service delivery is global in scope, covering the U.S., Europe, the Middle East, and Asia, supported by direct experience working with FDA, NIH, CDC, EMA, Health Canada, and ICH/GHTF frameworks.

The company is led by founder and president Ron Arkin (25+ years in regulatory affairs, quality assurance, sterilization, and validation; 30 successful 510(k) and international submissions personally led) and VP Paul Sumner (25+ years in healthcare regulatory consulting). The senior bench includes consultants with prior FDA inspection experience and clinical research leadership across sponsors and CROs. ACG has no disclosed revenue, no institutional investors, no M&A activity, no funding rounds, and no AI/technology product offerings; it is a founder-led boutique consultancy whose core technology is human expertise. The firm holds professional affiliations with RAPS, FDLI, ASQ, SEMDA, and the University of Georgia Regulatory Affairs Graduate Education Program, and operates with 11-50 employees.

Name

Arkin Consulting Group

Legal name

Arkin Consulting Group, LLC.

Website

https://arkinconsulting.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Arkin Consulting Group is a privately held boutique consultancy founded in 1994 in Canton, Georgia, providing FDA and ISO regulatory, quality assurance, and clinical management services to small, medium, and multi-national medical device, pharmaceutical, biologics, and veterinary product companies across the U.S., Europe, the Middle East, and Asia.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Engineering, Accounting, Research, Management (8700)

akta.pro primary industry

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

akta.pro secondary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Regulatory affairs consulting
• FDA compliance services
• Quality assurance consulting
• Medical device consulting
• Clinical trial management

Headquarters

HQ city

Canton

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 & Quality Consulting Services: Professional consulting services including regulatory affairs, quality assurance, validation, clinical management, and training. Services provided to medical device, pharmaceutical, biologics, and veterinary product companies seeking FDA and ISO compliance.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Arkin Consulting Group (ACG) is a full-service regulatory, quality assurance, and clinical management consulting firm serving medical device, pharmaceutical, biologics, and veterinary product companies. Since 1994, the firm has delivered FDA and ISO regulatory consulting, regulatory submissions (510(k), PMA, NDA, IND, IDE), quality system development and audits, process and software validation, and clinical trial planning and monitoring, plus international market entry support including CE Mark dossiers and U.S. Agent Services.

Product overview

Arkin Consulting Group is a full-service regulatory, quality assurance, and clinical consulting firm offering five integrated service areas: Quality Assurance & Compliance Services (covering audits, ISO certification, CE-Mark, and quality systems), Strategic Regulatory Consulting & Submissions (PMA, 510(k), NDA, IND filings), Clinical Planning, Management & Monitoring (clinical trials design and oversight), International Experience Services (global market entry and U.S. Agent services), and Validation Consulting (process and software validation). These services are designed to help medical device, pharmaceutical, biologics, and veterinary product companies achieve FDA and ISO regulatory compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Quality Assurance & Compliance Services

Quantifiable outcome

• 100% clearance rate for all submissions when sponsor provided data
• +1 more outcomes

Named customers6 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Eleven partnerships are on record, tiered moderate, minor and core.

• Regulatory Affairs Professional Society (RAPS)moderateOthersProfessional organization for regulatory affairs professionals. ACG is affiliated with RAPS, which provides networking, education, and professional development resources in regulatory affairs.
• Food and Drug Law Institute (FDLI)moderateOthersInstitute providing education and scholarly publications on food and drug law. ACG maintains affiliation for regulatory insights and professional connections.
• American Society for Quality (ASQ)moderateOthersProfessional organization for quality professionals. ACG team members are members, and the firm leverages ASQ resources and expertise in quality systems.
• Southeastern Medical Device Association (SEMDA)minorOthersRegional trade association for medical device companies in the Southeastern U.S. Provides networking opportunities and industry advocacy.
• University of Georgia Regulatory Affairs Graduate Education ProgramminorOthersAcademic program in regulatory affairs. ACG affiliation suggests involvement in education and talent development.
• U.S. Food & Drug Administration (FDA)coreOthersACG works with FDA on regulatory submissions, inspections, and compliance matters. Experience includes FDA-GMP workshops, regulatory inspections, and agency negotiations.
• National Institutes of Health (NIH)moderateOthersACG has experience working with NIH on regulatory and research-related matters.
• Centers for Disease Control (CDC)moderateOthersACG has regulatory experience involving CDC for public health-related medical products.
• Health CanadamoderateOthersInternational regulatory experience includes working with Health Canada for Canadian market access.
• European Medicines Agency (EMA)moderateOthersInternational regulatory expertise includes EMA for European market access and CE Mark submissions.
• International Conference on Harmonisation (ICH)moderateOthersACG applies ICH/GHTF guidelines in clinical development (Clinical CGP Development) and international regulatory strategy.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• ICON plc: Top-3 global CRO providing clinical research, regulatory affairs, and laboratory services to pharma/medical device sponsors. Comparable regulatory and clinical service lines but at enterprise scale with global delivery.
• Medpace: Mid-to-large CRO focused on clinical trial execution for medical device and pharma. Overlaps with ACG's clinical planning and management services but operates at a much larger scale with full-service global capabilities.
• Parexel International: Global CRO with deep regulatory consulting, clinical trial management, and medical device services. Comparable regulatory affairs and clinical consulting capabilities, though at large-enterprise scale across multiple geographies.
• IQVIA: Largest global CRO offering end-to-end clinical trial management, regulatory affairs, real-world evidence, and technology platforms. Serves as a broad incumbent whose regulatory and clinical services overlap with ACG's offerings, though at vastly larger scale.
• WuXi AppTec: Global CRO/CDMO providing regulatory affairs, clinical, and laboratory services across pharma and medical devices. Comparable regulatory and clinical services, though primarily serves as a broad incumbent at much larger scale.

Direct peers

• Oriel STAT A MATRIX: Regulatory, quality, and clinical consulting firm specializing in FDA compliance, medical device submissions, and ISO 13485/QSR for life sciences. Closely comparable service portfolio and target client base to ACG.
• Biologics Consulting Group: Boutique regulatory affairs and quality consulting firm serving biologics, vaccines, cell/gene therapy, and medical device companies with FDA submissions, GMP, and quality systems. Directly comparable to ACG in service mix, target clients, and boutique scale.
• Greenleaf Health: Regulatory and quality consulting firm providing FDA strategic consulting, medical device submissions, and compliance services to pharma/biotech. Highly comparable to ACG's regulatory submission and quality systems practice.
• Makro Scientific: Regulatory and quality compliance consulting firm supporting medical device, pharmaceutical, and biotech clients with FDA submissions, validation, and quality systems. Comparable boutique regulatory consultancy with overlapping service lines.
• MethodSense: Life science regulatory and quality consulting firm providing FDA submissions, quality systems, and compliance services to medical device and pharma companies. Similar boutique consulting model and service scope to ACG.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/e/-9nfqq7-gbaqdf6n-1o/vgh/3192910

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 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 Arkin Consulting Group