Gates Healthcare Associates

What Gates Healthcare Associates does

Gates Healthcare Associates (GHA) is a privately held pharmaceutical compliance consulting firm founded in 1995 by Ernie Gates and headquartered in Middleton, Massachusetts. The firm serves two primary client segments: 503A compounding pharmacies requiring USP <795>, <797>, and <800> compliance support and state board inspections, and 503B outsourcing facilities operating under FDA cGMP requirements. Its flagship service is non-resident license inspections, a state-mandated engagement that is accepted by 19 state boards; GHA holds approvals to conduct inspections in 19 states for 503A and 2 states for 503B, with active pursuit of nationwide coverage across all 50 states.

The service portfolio spans regulatory compliance consulting (USP, DEA, FDA, accreditation support from ACHC, NABP, URAC), gap analyses and mock inspections, policies and procedures development, training and education programs, and pharmacy sales/acquisition support. GHA also sells productized SOP templates as a standalone offering. The firm operates without proprietary technology or software — it is a labor-intensive, expertise-led consulting model where pharmacist-credentialed inspectors (R.Ph., PharmD, FACA, FIACP) and former regulators deliver services directly to client sites and through advisory engagements.

Revenue derives from project-based professional services fees quoted on an initial consultation call, with no publicly disclosed rate cards. The go-to-market is sales-led and consultative: a 30-minute scoping call produces a quote tied to state requirements and engagement scope. GHA markets through content (Compliance Corner blog), email newsletter, and industry association affiliations (APC, ASHP, NCPA, NHIA, AMCP Foundation, ACA). The firm has no disclosed external funding, is founder-led, and operates with a small core team supplemented by senior associates and consultants.

Name

Gates Healthcare Associates

Legal name

Gates Healthcare Associates, Inc.

Website

https://gateshealthcareassociates.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

1–10 employees

Short description

Gates Healthcare Associates is a pharmaceutical compliance consulting firm serving 503A compounding pharmacies and 503B outsourcing facilities with regulatory inspections, USP/DEA/FDA compliance, training, and SOP templates. Founded in 1995, it operates nationwide from Middleton, MA with 31+ years of experience.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Compliance Consulting

SIC

Services-Health Services (8000)

akta.pro primary industry

Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE)

Keywords

• Pharmaceutical compliance consulting
• Compounding pharmacy inspections
• USP 795 797 800 compliance
• 503A 503B regulatory advisory
• FDA inspection readiness

Headquarters

HQ city

Middleton

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

Revenue model

1. Regulatory Compliance Consulting Services: Professional consulting services for 503A compounding pharmacies and 503B outsourcing facilities. Services include inspections, gap analyses, mock inspections, training, and ongoing regulatory advisory. Revenue appears to be project-based consulting fees with straightforward pricing quoted on first call.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Gates Healthcare Associates is a pharmaceutical consulting firm that provides non-resident license inspections, mock inspections, gap analyses, and regulatory compliance advisory services for 503A compounding pharmacies and 503B outsourcing facilities. Offerings include USP 795/797/800, DEA, and FDA compliance consulting, accreditation support, SOP templates, training programs, and pharmacy transaction support.

Product overview

Gates Healthcare Associates offers a comprehensive suite of pharmaceutical compliance consulting services organized around two primary client segments: 503A compounding pharmacies and 503B outsourcing facilities. The core portfolio includes non-resident license inspections (their flagship service), USP compliance consulting (covering <795>, <797>, <800>), DEA compliance consulting, FDA compliance services, and accreditation support. Additional services include training and education programs, pharmacy sales and acquisition support, and Policies & Procedures (SOP templates) available for purchase. The company operates as a services-led consulting firm rather than a software platform, with all offerings delivered through expert consultants and compliance specialists.

Differentiator

Problem solved

Functional benefit

Products and services

• Non-Resident License Inspections State-required inspections for out-of-state licensure, conducting thorough, board-ready inspections aligned with current USP standards (795, 797, 800) and state expectations for 503A compounding pharmacies and 503B outsourcing facilities.
• USP Compliance Consulting Gap analyses, mock inspections, and compliance support for USP Chapters 795, 797, and 800 covering non-sterile compounding, sterile compounding, and hazardous drug handling standards.
• DEA Compliance Consulting Controlled substance compliance services including DEA inspection readiness, drug diversion prevention, audit preparation, and regulatory consulting covering DSCSA, CSERA, and CSIEA requirements.
• FDA Compliance Services FDA inspection readiness, mock inspections, Form 483 response and remediation, and quality system evaluations for facilities operating under FDA oversight.
• Accreditation Support Assistance with meeting accreditation standards from leading healthcare accreditation bodies including ACHC, NABP (DMEPOS, VAWD, VIPPS, CPPA), and URAC for specialty pharmacy accreditation.
• 503A Compounding Pharmacy Services Comprehensive compliance services for 503A compounding pharmacies including operational assessments, policies and procedures review, lab design and buildouts, transactions and transitions support, and consultant of record services.
• 503B Outsourcing Facility Services Compliance services for 503B outsourcing facilities under cGMP requirements, including FDA inspection readiness, quality system assessments, Form 483 response, operational assessments, facility expansion, and lab design and buildouts.
• Training & Education Programs Practical training programs for pharmacy teams covering compounding competency (USP 795, 797, 800), regulatory preparedness, DEA and controlled substance compliance, and tailored team development.
• Pharmacy Sales & Acquisition Support Regulatory and operational oversight for pharmacy transactions including business valuation, operational compliance inspection, buyer vetting, regulatory documentation evaluation, negotiation support, acquisition support, and transaction strategy.
• Policies & Procedures (SOP Templates) Professionally developed SOP templates aligned with current USP standards and regulatory expectations, available for purchase.

Quantifiable outcome

• Board-ready inspection reports delivered within 7-10 business days with expedited service available
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Six partnerships are on record, tiered minor.

• Alliance for Pharmacy Compounding (APC)minorOthersIndustry association partnership. APC represents pharmacists, pharmacies, and technicians committed to pharmacy compounding. GHA displays APC logo as part of their partner network.
• ASHPminorOthersAmerican Society of Health-System Pharmacists partnership. ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings.
• AMCP FoundationminorOthersAcademy of Managed Care Pharmacy Foundation partnership supporting pharmacy and healthcare outcomes.
• NCPAminorOthersNational Community Pharmacists Association partnership representing independent community pharmacists.
• NHIAminorOthersNational Home Infusion Association partnership representing providers of home and alternate site infusion services.
• ACAminorOthersAmerican Chemistry Association partnership related to pharmaceutical compounding standards and practices.

Scale indicators4 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Cardinal Health: Cardinal Health is a major pharmaceutical distributor and healthcare services company with compounding pharmacy supply, consulting, and compliance resources. It is a broad incumbent with overlapping compounding-pharmacy-relevant capabilities, though delivered as part of a much wider portfolio rather than GHA's specialized focus.
• McKesson: McKesson is one of the largest pharmaceutical distributors and healthcare services companies, offering compounding pharmacy support, compliance resources, and accreditation assistance. It is a broad incumbent that touches the 503A/503B customer base but does not specialize in regulatory inspections the way GHA does.
• Medisca: Medisca is a global supplier of compounding pharmacy ingredients, equipment, and educational resources, including compliance and training content for 503A pharmacies. It is a broad incumbent overlapping GHA's customer base and adjacent in compliance support, though its core business is product supply rather than inspection services.
• Fagron: Fagron is a global leader in pharmaceutical compounding, supplying APIs, excipients, and compounding pharmacy support services including training and regulatory resources. It is a broad incumbent that serves the same compounding pharmacy customer base and offers adjacent compliance and educational services, but at much greater scale and geographic breadth than GHA.
• NSF Health Sciences: NSF Health Sciences provides regulatory consulting, training, and certification services across pharmaceuticals, medical devices, and dietary supplements. It is a broad incumbent in pharma regulatory consulting, with overlapping GxP/QSR capabilities to GHA but operating at much greater scale and across a wider portfolio.

Direct peers

• Lachman Consultants: Lachman Consultants is an FDA regulatory and compliance consulting firm serving pharmaceutical manufacturers and 503B outsourcing facilities. It is a direct peer in the GxP/FDA compliance advisory space, particularly overlapping GHA's FDA inspection readiness, Form 483 response, and quality system assessment services.
• CriticalPoint: CriticalPoint provides compounding pharmacy compliance training, USP 797/800 education, and sterile compounding competency assessment tools. It is a direct peer because it serves the same 503A/503B audience with overlapping training and compliance readiness services that compete for the same customer wallet.
• Commissioning Agents Inc (CAI): CAI is a consulting firm that provides commissioning, qualification, validation, and regulatory compliance services to pharmaceutical and life sciences manufacturers. It is a direct peer in cGMP compliance and quality system advisory, overlapping GHA's 503B outsourcing facility services.
• PharmCon: PharmCon (FreeCE) provides continuing education and compliance training for pharmacists and pharmacy technicians nationwide. It is a direct peer in pharmacy regulatory education and overlaps GHA's Training & Education and USP compliance content offerings for the same practitioner audience.
• LP3 Network: LP3 Network delivers compounding pharmacy education, CE programs, and compliance training for pharmacists and technicians. It competes directly with GHA's Training & Education line and is similarly positioned around USP 795/797/800 competency building for the 503A/503B market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/gatesconsult
• Facebookfacebook.com/gateshealthcare

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 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 Gates Healthcare Associates