Lachman Consultant Services

What Lachman Consultant Services does

Lachman Consultant Services, Inc. is a privately held, independent FDA regulatory compliance and consulting firm founded in 1978 by Leon Lachman, Ph.D., and currently led by President & CEO Frances Zipp with Roy Sturgeon, Ph.D. as Chairman. Headquartered in Westbury, New York, with additional offices in Bethesda, Maryland, Dublin, Ireland, and Lucerne, Switzerland, the firm operates through three integrated practice groups: Compliance, Regulatory Affairs, and Science & Technology. Its bench consists of former senior-level FDA managers, FDA reviewers, and industry experts who deliver advisory, audit, and remediation services to pharmaceutical, biotechnology, biologics, medical device, advanced therapy (cell and gene therapy), and related life sciences companies.

The firm's core offering is high-skill professional services rather than software or technology products. Service lines span FDA document preparation and review (NDAs, INDs, ANDAs, 510(k)s, PMAs, DMFs, BLAs), compliance problem resolution, mock FDA inspections, data integrity programs, due diligence audits, facilities design and validation, systems evaluation, training programs, and remote consulting engagements. Underlying the offering are proprietary consulting methodologies and institutional knowledge of FDA processes accumulated over 47+ years, organized around vertical market expertise in pharmaceuticals, biologics, advanced therapies, medical devices, and related industries (API, diagnostics, dietary supplements, digital health, veterinary).

The business model is professional services consulting billed on a project/engagement basis at quote-based pricing, with revenue derived entirely from professional service fees. The go-to-market is relationship-driven direct sales leveraging industry reputation, thought leadership (blog, webinars, whitepapers, Lachman Learning series), active presence at major industry conferences (PDA, TIDES, CPhI, MedTech), and referrals from law firms and investment groups. The firm serves clients ranging from one-person startups to Fortune 500 multinational pharmaceutical companies, with primary end-markets in pharma, biologics/biotech, medical devices, and advanced therapies, and secondary segments in law firms, investment groups, and dietary supplement manufacturers.

Name

Lachman Consultant Services

Legal name

Lachman Consultant Services, Inc.

Website

https://lachmanconsultants.com

Company type

Private

Founded year

1978

Operating status

Operating

Headcount range

51–100 employees

Short description

Lachman Consultant Services is a privately held FDA regulatory compliance and consulting firm founded in 1978, serving pharmaceutical, biotech, biologics, medical device, and advanced therapy companies with project-based advisory services delivered by former FDA officials across offices in the US, Ireland, and Switzerland.

Ownership category

akta.pro rank

Headquarters

HQ city

Westbury

HQ country

United States

HQ region

North America

Offices4 records

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: Professional consulting services billed on a project or engagement basis. Services include FDA regulatory affairs, compliance problem resolution, quality assurance, data integrity, mock FDA inspections, training, and technical assistance. Revenue is derived from professional service fees for advisory, audit, and consulting engagements with pharmaceutical, biotech, biologics, medical device, and related life sciences companies.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Lachman Consultants provides professional FDA regulatory compliance, regulatory affairs, and science & technology consulting services to pharmaceutical, biotechnology, biologics, medical device, and related life sciences companies. Services include regulatory filing preparation (NDAs, INDs, ANDAs, 510(k)s, PMAs, BLAs, DMFs), compliance problem resolution, mock FDA inspections, data integrity consulting, quality systems design, due diligence audits, and training, delivered by former senior-level FDA managers and industry experts.

Product overview

Lachman Consultant Services is a regulatory compliance and consulting firm that operates as a unified service offering rather than a software platform. The company provides FDA compliance consulting and regulatory affairs services organized into distinct practice areas: FDA-Related Services (document preparation, compliance resolution, regulatory affairs assistance, training, audits), Compliance Services, Regulatory Affairs, Data Integrity Services, Mock FDA Inspections, Analytical Services, Biomonitoring Support, Strategic Planning, Due Diligence Audits, Quality Assurance and Controls, Scientific and Technical Assistance, Systems Evaluation, Facilities Design or Validation, System Process Validation or Qualification, Training Programs, and Remote Services. The firm serves multiple market verticals including Pharmaceuticals, Biologics, Advanced Therapies (cell and gene therapies), Medical Devices, and Related Industries (API, diagnostics, dietary supplements, digital health, veterinary products). Services are delivered by former FDA officials and industry experts, emphasizing hands-on consulting rather than software products.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA-Related Services Comprehensive FDA regulatory consulting including document preparation/reviews (NDAs, INDs, ANDAs, 510(k)s, PMAs, DMFs), compliance problem resolution, regulatory affairs strategic assistance, training, audits, pharmacovigilance/drug safety surveillance, and special services.
• Compliance Services Full range of mission-critical compliance services including designing and implementing effective business processes, assuring sustainable compliance through integration of scientific, technical, and regulatory principles.
• Regulatory Affairs Consulting Regulatory affairs consulting group comprised of former senior-level FDA managers and FDA reviewers providing assistance with regulatory filings, ANDAs, NDAs, DMFs, and other FDA regulatory forms.
• Data Integrity Services GxP Data Integrity consulting critical to patient safety, regulatory compliance, and business success, covering managing vulnerabilities and risk across company operations for all GxP data.
• Mock FDA Inspections Comprehensive mock FDA inspection services including facility inspections, documentation reviews, team training, and report generation to prepare clients for actual FDA inspections, delivered remotely and on-site.
• Analytical Services Analytics services providing functionality and flexible, scalable usability that meets diverse user needs according to targeted business goals.
• Biomonitoring Support Biomonitoring services addressing challenges of auditing and quantifying identity, purity, quality, safety, efficacy, and other requirements for authorization.
• Strategic Planning Strategic planning services featuring global product development strategy, clinical/non-clinical/CMC/regulatory gap analysis, product and indication prioritization, and regulatory pathway optimization.
• Due Diligence Audits Due diligence audit services for strategic mergers and acquisitions including assessment of compliance, identification of deficiencies, evaluation of supply chain and product pipeline capabilities.
• Quality Assurance and Controls Quality assurance and control services including evaluating written procedures, developing laboratory systems and specifications, corporate oversight programs, and organizational structure assessments.
• System Process Validation or Qualification System and process validation or qualification services including programmatic assistance, computer systems validation, 21 CFR Part 11 compliance, and validation/qualification policies and protocols.
• Training Programs Regulatory compliance and affairs training programs for all organizational levels including GMP programs, regulatory programs, generic drugs program, and clinical/bioanalytical programs.
• Remote Services Remote consulting services enabling expert support for quality systems implementation, policy and SOP writing, application review, audits, data integrity reviews, training, and FDA meeting preparation.
• Pharmaceuticals Consulting Pharmaceutical regulatory compliance consulting serving pharmaceutical companies, generic drug companies, OTC product companies, and contract manufacturers with quality systems design and regulatory submission support.
• Biologics Consulting Regulatory compliance and consulting services for biologics including monoclonal antibodies, cell and gene therapies, vaccines, and biosimilars with support across development and commercialization.
• Advanced Therapies Consulting Strategic compliance and regulatory support for cell and gene therapies, tissue-engineered products, and other ATMPs with expertise in FDA CBER/CDER and EMA ATMP frameworks.
• Medical Device Consulting Comprehensive regulatory and compliance support for medical device manufacturers including QMSR, EU MDR, and ISO 13485 requirements, 510(k), PMA, De Novo submissions, and quality systems auditing.
• Related Industries Consulting Regulatory consulting for related industries including API companies, diagnostics and IVD companies, dietary supplement manufacturers, compounding pharmacies, digital health and SaMD firms, and veterinary product manufacturers.

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators3 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Advarra: Advarra provides regulatory compliance, IRB, and technology-enabled consulting services to life sciences and clinical research sponsors. Its regulatory and quality consulting practice overlaps with Lachman's compliance and GCP-adjacent services.
• ProPharma Group: ProPharma Group is a regulatory compliance, quality, and pharmacovigilance consulting firm serving pharma, biotech, and medical device companies. It is one of the closest direct competitors to Lachman, offering overlapping FDA consulting, mock inspections, and quality systems services.
• PharmaLex: PharmaLex provides regulatory affairs, quality, and pharmacovigilance consulting across the product lifecycle for pharma and biotech. Its service mix in regulatory strategy and compliance mirrors Lachman's core offerings, and its multi-jurisdiction footprint makes it a directly comparable peer.
• NDA Group: NDA Group is a regulatory affairs and drug development consulting firm supporting pharma and biotech across FDA/EMA submissions. Its focus on regulatory strategy, CMC, and due diligence closely parallels Lachman's Regulatory Affairs and Science & Technology practice groups.
• Voisin Consulting Life Sciences: Voisin Consulting provides regulatory, clinical, and quality consulting for medical devices, IVDs, and combination products. It competes with Lachman specifically in the Medical Device consulting market, particularly for EU MDR and FDA pathway work.
• Regulatory Pharma Net: Regulatory Pharma Net is a specialized regulatory affairs consultancy serving pharma and biotech with submission strategy and compliance services. It is a similarly sized, niche-focused peer competing directly with Lachman for FDA regulatory consulting engagements.

Broad incumbents

• Parexel International: Parexel is a global CRO with a sizable regulatory and consulting practice serving pharma and biotech. It competes with Lachman for regulatory affairs and submission work but as part of a much broader clinical and commercialization portfolio.
• IQVIA: IQVIA is the world's largest CRO with extensive regulatory affairs, quality compliance, and technology-enabled services. It competes broadly with Lachman across pharma/biotech regulatory work but as a one-stop-shop offering clinical, real-world, and commercial services.
• ICON plc: ICON is a global CRO with a regulatory and consulting division serving pharma, biotech, and medical device sponsors. It overlaps with Lachman in regulatory strategy and quality but competes predominantly through large enterprise clinical engagements.
• Charles River Laboratories: Charles River provides research, manufacturing, and consulting services to pharma and biotech, including regulatory and quality support. While its core is discovery and manufacturing, its consulting arm competes with Lachman in regulatory and CMC services.

Market position

Strengths5 records

Weaknesses1 record

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/LachmanConsult

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries2 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 Lachman Consultant Services