Lachman Consultants
Lachman Consultant Services, Inc.
Verified
Global Regulatory Compliance Experts. Since 1978, Lachman Consultants has offered compliance, regulatory affairs, and technical services to pharmaceutical, medical device, and biologics clients worldwide.
Lachman Consultants is a global regulatory compliance expert firm. Through long-standing mastery of technical and regulatory consultation services, Lachman serves all areas of global regulatory compliance for Pharmaceutical, Biotechnology, Biologics, CGT, Device and Allied Health Industries. Services include Mock FDA Inspections, FDA 483 Response, Regulatory Affairs, Compliance, validation, and quality systems. HQ: Westbury, NY; offices in Bethesda MD, Dublin, and Lucerne.
About
**Who they are**
Lachman Consultants has been providing global regulatory compliance expertise since 1978 to pharmaceutical, medical device, and biologics clients. They offer a diverse portfolio of capabilities focused on FDA-related services.
**Expertise & scope**
* Assisting clients in reviewing and preparing key documents for FDA review.
* Providing specific, actionable recommendations for compliance problem resolution.
* Developing drug diversion prevention and counterfeit investigation programs.
* Conducting mock FDA inspections and audits, including facility inspections, documentation reviews, and team training.
* Offering data integrity and governance consulting, support, and services critical to patient safety and business success.
* Providing analytical services with a focus on accuracy, performance, and operational execution.
* Supporting biomonitoring services to address challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
* Developing custom training programs on FDA regulations.
**Reputation / proof points**
* Founded in 1978.
Lachman Consultants has been providing global regulatory compliance expertise since 1978 to pharmaceutical, medical device, and biologics clients. They offer a diverse portfolio of capabilities focused on FDA-related services.
**Expertise & scope**
* Assisting clients in reviewing and preparing key documents for FDA review.
* Providing specific, actionable recommendations for compliance problem resolution.
* Developing drug diversion prevention and counterfeit investigation programs.
* Conducting mock FDA inspections and audits, including facility inspections, documentation reviews, and team training.
* Offering data integrity and governance consulting, support, and services critical to patient safety and business success.
* Providing analytical services with a focus on accuracy, performance, and operational execution.
* Supporting biomonitoring services to address challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
* Developing custom training programs on FDA regulations.
**Reputation / proof points**
* Founded in 1978.
Additional information
Lachman Consultants emphasizes an integrated approach, combining scientific and technical expertise to deliver specific, actionable recommendations. They are recognized as a go-to firm for organizations facing difficult compliance challenges. Their services are designed to help clients stay current with evolving regulatory and technical environments, particularly as AI-driven technologies reshape manufacturing. They focus on assuring sustainable compliance through the optimal integration of scientific, technical, and regulatory principles.
Key Highlights
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Global regulatory compliance experts since 1978.
Source
“Since 1978, Lachman Consultants has offered compliance, regulatory affairs, and technical services to pharmaceutical, medical device, and biologics clients worldwide.”
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Specializes in FDA-related services including compliance problem resolution and regulatory affairs strategic assistance.
Source
“Preventing and resolving compliance issues is at the heart of Lachman Consultants’ experience and expertise.”
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Offers comprehensive mock FDA inspection services to prepare clients for actual inspections.
Source
“That’s why we offer comprehensive mock FDA inspection services to help you prepare for an actual FDA inspection.”
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Provides data integrity and governance consulting critical to patient safety and business success.
Source
“Make Lachman Consultants’ Data Integrity Services an essential part of your organization’s journey toward a sustainable, compliant, and successful company-wide data governance and integrity program.”
Certifications & Trust Signals
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Extensive experience assisting hundreds of domestic and international clients.
Source
“Lachman Consultants has assisted hundreds of domestic and international clients in reviewing and preparing key documents for review by FDA”
Buyer Snapshot
Best for
- Companies seeking expert guidance on FDA regulations.
- Organizations needing assistance with compliance problem resolution.
- Firms preparing for FDA inspections or audits.
How engagement typically works
- Collaborative problem-solving.
- Customized program development.
- Strategic regulatory assistance.
Typical deliverables
- Document review and preparation.
- Compliance strategy recommendations.
- Mock inspection reports and feedback.
- Data integrity program development.
- Biomonitoring support and data analysis.
Good to know
- Best when requiring specialized FDA regulatory and compliance expertise.
HQ:
Westbury, NY, US
Website:
lachmanconsultants.com
Public email:
m.taylor@lachmanconsultants.com
Phone:
+1 (516) 222-6222
Languages:
English
Timezones:
America/New_York
Access:
Verified
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Drugs, Medical devices
Portfolio:
6-25, 26-100, 100+
Flags:
class_iii, ivd, high_portfolio
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Starting from:
USD 1,600
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Product Type:
drugs, devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Regulatory Consulting
Contact Category:
permanent
Contact Site:
external
Device Class:
I, II, III
Ivd Class:
A, B, C, D
Product Types:
medical_device, ivd, pharmaceutical
Service Scope:
liaison_only, official_correspondent, registration_listing_admin, regulatory_advisory, quality_systems_consulting, validation_services, compliance_auditing
Specialization:
Global regulatory compliance for pharmaceutical, medical device, and biotechnology companies
Expertise:
FDA regulatory affairs, Quality systems (cGMP), Validation services, Compliance auditing, Regulatory strategy
Inspection Support:
Yes
510k_submission_services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Regulatory Pathway Assessment, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, Combination product
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Years Experience:
46
Num510k Submitted:
120
Device Panels:
cardiovascular, general_surgery, neurology, radiology, dental, gastroenterology
Technology Types:
samd, combo_product
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Ex FDA:
Yes
Engagement Models:
Project-based
Additional us_agent_fda Details
Registration Support
Implied through regulatory affairs assistance
Product Types
Pharmaceuticals, Medical Devices, Biologics, Combination Products
Recall Support
Implied through regulatory affairs assistance
Inspection Support
Mock FDA Inspections & Audits, Facility Inspections, Documentation Reviews, Team Training
Onboarding Steps
Custom program development based on client needs and existing initiatives.
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