FDA Compliance Group
FDA Compliance Group LLC
FDA Compliance Group LLC offers expert FDA consulting services, including mock audits, gap analysis, Form 483 responses, and warning letter assistance. They help FDA-regulated industries maintain compliance.
FDA Compliance Group LLC provides specialized consulting services to help companies navigate and maintain compliance with all FDA requirements. With a team of former FDA employees and industry experts, they offer comprehensive support for mock audits, gap analysis, and responding to FDA Form 483 observations and Warning Letters. Their services extend to FDA labeling and website reviews, ensuring marketing materials and product labels adhere to current regulations. They also assist with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting), crucial for medical device manufacturers. FDA Compliance Group serves a wide range of FDA-regulated industries, including medical devices, drugs, dietary supplements, clinical trials, and food & tobacco. Their expertise helps clients avoid regulatory actions, product recalls, and facility shutdowns, ensuring operational continuity and product integrity.
About
**Who they are**
FDA Compliance Group is a full-service consulting firm specializing in United States Food and Drug Administration (U.S. FDA) and Global Regulatory Affairs services. They cater to industries regulated by the FDA.
**Expertise & scope**
* U.S. FDA Regulatory Affairs and Global Regulatory Body Strategy and Negotiations
* U.S. FDA Product Submissions and Approvals (LDT, IDE, 510k, PMA, BLA, IND, and NDA)
* Global Regulatory Product Submissions, Approvals, and Regulatory Compliance
* U.S. FDA Clinical Trial/Study Protocol Development and Execution
* U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) Regulatory Compliance
* ISO 13485/ISO 9001 Implementation and Regulatory Compliance
* EU Technical File Development, Product CE Marking, and MDD/IVDD Regulatory Compliance
* U.S. FDA and IEC 62304 Software Development Process Implementation and Compliance
* U.S. FDA Establishment Registration and Device Listing
* U.S. CLIA/CAP/New York State Regulatory Compliance
**Reputation / proof points**
* Copyright © 2010-2020 indicates operations at least since 2010.
FDA Compliance Group is a full-service consulting firm specializing in United States Food and Drug Administration (U.S. FDA) and Global Regulatory Affairs services. They cater to industries regulated by the FDA.
**Expertise & scope**
* U.S. FDA Regulatory Affairs and Global Regulatory Body Strategy and Negotiations
* U.S. FDA Product Submissions and Approvals (LDT, IDE, 510k, PMA, BLA, IND, and NDA)
* Global Regulatory Product Submissions, Approvals, and Regulatory Compliance
* U.S. FDA Clinical Trial/Study Protocol Development and Execution
* U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) Regulatory Compliance
* ISO 13485/ISO 9001 Implementation and Regulatory Compliance
* EU Technical File Development, Product CE Marking, and MDD/IVDD Regulatory Compliance
* U.S. FDA and IEC 62304 Software Development Process Implementation and Compliance
* U.S. FDA Establishment Registration and Device Listing
* U.S. CLIA/CAP/New York State Regulatory Compliance
**Reputation / proof points**
* Copyright © 2010-2020 indicates operations at least since 2010.
Additional information
FDA Compliance Group provides comprehensive support for a wide array of FDA-regulated industries, including Medical Device, In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx) Device, Combination Drug/Device, Clinical Laboratory, Biological, and Pharmaceutical sectors. Their services encompass strategic regulatory affairs, product submissions and approvals across various FDA pathways, and adherence to quality system regulations. They also offer expertise in international compliance, including ISO standards and EU CE marking requirements. For clients navigating complex regulatory landscapes, FDA Compliance Group assists with establishment registration, device listing, and specific state-level compliance like CLIA and New York State regulations.
Key Highlights
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Specializes in U.S. FDA and Global Regulatory Affairs for Medical Devices, IVDs, Pharmaceuticals, and more.
Source
“specializes in providing a wide range of United States Food and Drug Administration (U.S. FDA) and Global Regulatory Affairs services to the Medical Device, In Vitro Diagnostic (IVD) Device, Companion Diagnositc (CDx) Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries.”
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Offers support for a broad spectrum of FDA product submissions including LDT, IDE, 510k, PMA, BLA, IND, and NDA.
Source
“U.S. FDA Product Submissions and Approvals (LDT, IDE, 510k, PMA, BLA, IND and NDA)”
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Provides assistance with U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) compliance.
Source
“U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) Regulatory Compliance”
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Expertise includes ISO 13485/ISO 9001 implementation and EU Technical File development for CE Marking.
Source
“ISO 13485/ISO 9001 Implementation and Regulatory Compliance EU Technical File Development, Product CE Marking and MDD/IVDD Regulatory Compliance”
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Assists with U.S. FDA Establishment Registration and Device Listing.
Source
“U.S. FDA Establishment Registration and Device Listing”
Certifications & Trust Signals
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Operating since at least 2010.
Source
“FDA Compliance GroupCopyright © 2010-2020All rights reserved.”
Buyer Snapshot
Best for
- Companies in the Medical Device, IVD, Pharmaceutical, and Biological industries seeking FDA regulatory guidance.
- Businesses requiring assistance with product submissions and approvals.
- Organizations needing support for quality system regulation and international compliance.
How engagement typically works
- Consulting services for regulatory strategy and negotiations.
- Support for product submissions and approvals.
- Assistance with compliance implementation and maintenance.
Typical deliverables
- FDA product submissions (e.g., 510k, PMA, NDA)
- Quality System Regulation (QSR/GMP) compliance strategies
- ISO 13485/ISO 9001 implementation plans
- EU Technical Files and CE Marking documentation
- FDA Establishment Registration and Device Listing
Good to know
- Best when requiring specialized expertise in U.S. FDA and global regulatory affairs for regulated products.
HQ:
New York, US
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+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,600
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Annual Renewal Support:
No
Registration Support:
No
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Recall Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Adverse Event Reporting (MDR/AER), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Medical Device, In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx) Device, Combination Drug/Device, Clinical Laboratory, Biological, Pharmaceutical
Registration Support
Yes
