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 with document preparation and reviews for FDA submissions.
* Providing compliance problem resolution and strategic regulatory affairs assistance.
* 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, supporting GxP data quality and risk management.
* Providing analytical services with a focus on accuracy and actionable alternatives.
* Supporting biomonitoring services to address challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
* Developing and delivering training programs on FDA-related topics, including custom programs.
**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 with document preparation and reviews for FDA submissions.
* Providing compliance problem resolution and strategic regulatory affairs assistance.
* 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, supporting GxP data quality and risk management.
* Providing analytical services with a focus on accuracy and actionable alternatives.
* Supporting biomonitoring services to address challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
* Developing and delivering training programs on FDA-related topics, including custom programs.
**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 navigate complex regulatory environments, prepare for inspections, and ensure sustainable compliance through the optimal integration of scientific, technical, and regulatory principles. They also highlight their experience in addressing citizen petitions and formulating strategies for patents.
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
“Experience Excellence in GxP Data Integrity critical to Patient Safety, Regulatory Compliance and Business Success.”
Certifications & Trust Signals
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Founded in 1978, indicating extensive experience in the field.
Source
“Since 1978, Lachman Consultants has offered compliance, regulatory affairs, and technical services to pharmaceutical, medical device, and biologics clients worldwide.”
Buyer Snapshot
Best for
- Companies seeking expert FDA regulatory compliance support.
- Organizations needing assistance with compliance problem resolution.
- Manufacturers preparing for FDA inspections.
How engagement typically works
- Consultative approach to problem-solving.
- Customized program development.
- Direct representation with regulatory bodies.
Typical deliverables
- Compliance strategies and recommendations.
- Prepared documentation for FDA review.
- Mock inspection reports and corrective action guidance.
- Training programs.
- Data integrity program development.
Good to know
- Best when requiring specialized expertise in FDA regulations for pharmaceuticals, medical devices, and biologics.
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 strategic assistance
Product Types
Pharmaceuticals, Medical Devices, Biologics, Combination Products
Recall Support
Implied through compliance problem resolution
Inspection Support
Mock FDA Inspections & Audits
Onboarding Steps
Custom program development based on client needs and existing initiatives.
US Entity State
US
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