Lachman Consultants
FDA Consulting Services
Global Regulatory Compliance Experts. Comprehensive FDA consulting services for pharmaceutical, medical device, and biotechnology companies.
Lachman Consultants is a global regulatory compliance expert firm providing comprehensive FDA consulting services. We specialize in regulatory affairs, quality systems, validation, and compliance for pharmaceutical, medical device, and biotechnology companies. Our team of experienced consultants helps clients navigate complex regulatory landscapes and achieve compliance with FDA regulations.
About
**Who they are**
FDA Consulting Services is a provider specializing in U.S. Agent services, FDA registration assistance, and compliance support for international companies.
**Expertise & scope**
* Facilitates U.S. Agent services.
* Assists with FDA registration processes.
* Offers compliance support tailored for international businesses.
**Reputation / proof points**
* Serves clients requiring U.S. regulatory representation.
FDA Consulting Services is a provider specializing in U.S. Agent services, FDA registration assistance, and compliance support for international companies.
**Expertise & scope**
* Facilitates U.S. Agent services.
* Assists with FDA registration processes.
* Offers compliance support tailored for international businesses.
**Reputation / proof points**
* Serves clients requiring U.S. regulatory representation.
Additional information
For international companies seeking to comply with U.S. Food and Drug Administration (FDA) regulations, FDA Consulting Services acts as the required U.S. Agent. This role is critical for foreign establishments that manufacture or market products subject to FDA oversight. The service ensures a U.S.-based point of contact for official FDA communications, including inspections and regulatory actions. Engagement typically involves establishing the necessary communication channels and ensuring timely responses to FDA inquiries.
Key Highlights
-
Provides dedicated U.S. Agent services for international companies.
Source
“FDA Consulting Services provides U.S. Agent services, FDA registration assistance, and compliance support for international companies.”
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Offers assistance with FDA registration and compliance.
Source
“FDA Consulting Services provides U.S. Agent services, FDA registration assistance, and compliance support for international companies.”
Buyer Snapshot
Best for
- International companies needing a U.S. Agent
- Businesses requiring FDA registration assistance
How engagement typically works
- Retainer-based U.S. Agent services
- Project-based registration support
Typical deliverables
- Designated U.S. Agent contact
- FDA registration filings
- Compliance guidance
Good to know
- Best when requiring a formal U.S. point of contact for FDA matters.
HQ:
San Francisco, United States
Languages:
English
Timezones:
America/New_York
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
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
Additional us_agent_fda Details
Registration Support
Yes
Product Types
Medical Devices, Pharmaceuticals, Food, Cosmetics, Tobacco
Recall Support
Implied through U.S. Agent role
Inspection Support
Implied through U.S. Agent role
