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 is a global regulatory compliance firm established in 1978, providing expert services to the pharmaceutical, medical device, and biologics industries worldwide.
**Expertise & scope**
* Assisting clients in reviewing and preparing key documents for FDA submission.
* Providing specific, actionable recommendations for compliance problem resolution.
* Developing and delivering training programs on FDA-related topics, including custom programs.
* Representing clients before the FDA and other regulatory bodies.
* Supporting diverse regulatory initiatives and activities, including preparing or correcting regulatory filings.
* Offering specialized services in Data Integrity, Mock FDA Inspections, Analytical Services, and Biomonitoring Support.
* Addressing challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
**Reputation / proof points**
* Founded in 1978, offering decades of experience.
* Possesses a stellar reputation for interpreting, addressing, and solving complex FDA-related problems.
* Recognized as a "go-to" firm for organizations facing difficult regulatory challenges.
Lachman Consultants is a global regulatory compliance firm established in 1978, providing expert services to the pharmaceutical, medical device, and biologics industries worldwide.
**Expertise & scope**
* Assisting clients in reviewing and preparing key documents for FDA submission.
* Providing specific, actionable recommendations for compliance problem resolution.
* Developing and delivering training programs on FDA-related topics, including custom programs.
* Representing clients before the FDA and other regulatory bodies.
* Supporting diverse regulatory initiatives and activities, including preparing or correcting regulatory filings.
* Offering specialized services in Data Integrity, Mock FDA Inspections, Analytical Services, and Biomonitoring Support.
* Addressing challenges in auditing and quantifying identity, purity, quality, safety, and efficacy.
**Reputation / proof points**
* Founded in 1978, offering decades of experience.
* Possesses a stellar reputation for interpreting, addressing, and solving complex FDA-related problems.
* Recognized as a "go-to" firm for organizations facing difficult regulatory challenges.
Additional information
Lachman Consultants emphasizes an integrated approach, combining scientific, technical, and regulatory expertise to deliver tailored solutions. They are adept at navigating the evolving regulatory landscape, including the impact of AI on pharmaceutical manufacturing, to ensure data integrity, traceability, and quality. Their services are designed to help clients achieve sustainable compliance, reduce risks, and maintain market access. For clients preparing for FDA inspections, Lachman Consultants offers comprehensive mock inspection services, including facility assessments, documentation reviews, and staff training, to identify and address potential deficiencies before an actual audit.
Key Highlights
-
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.”
-
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.”
-
Offers comprehensive mock FDA inspection services to prepare facilities and staff.
Source
“That’s why we offer comprehensive mock FDA inspection services to help you prepare for an actual FDA inspection.”
-
Provides expert support for Data Integrity, crucial for patient safety and business success.
Source
“Experience Excellence in GxP Data Integrity critical to Patient Safety, Regulatory Compliance and Business Success.”
Certifications & Trust Signals
-
Established in 1978, demonstrating extensive industry experience.
Source
“Since 1978, Lachman Consultants has offered compliance, regulatory affairs, and technical services to pharmaceutical, medical device, and biologics clients worldwide.”
-
Possesses a stellar reputation for interpreting, addressing, and solving complex FDA-related problems.
Source
“The Lachman FDA Consulting team has a stellar reputation for interpreting, addressing, and solving complex problems.”
-
Recognized as a "go-to" firm for organizations facing difficult regulatory challenges.
Source
“Resolving compliance problems is where Lachman Consultants truly shines. Lachman is the “go-to” firm when organizations are facing difficult challenges”
Buyer Snapshot
Best for
- Companies seeking expert guidance on FDA compliance.
- Organizations needing assistance with regulatory filings and submissions.
- Firms requiring support for data integrity and quality assurance programs.
- Businesses preparing for FDA inspections or audits.
How engagement typically works
- Collaborative problem-solving.
- Customized program development.
- Direct representation with regulatory bodies.
Typical deliverables
- Compliance strategy recommendations.
- Document review and preparation.
- Training programs.
- Mock inspection reports.
- 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:
devices, drugs
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, Facility Inspections, Documentation Reviews, Team Training
Onboarding Steps
Custom program development based on client needs and existing initiatives.
US Entity State
US
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare Lachman Consultants and other vetted providers — instant pricing, no RFQ needed.
