FDA Compliance Group
FDA Compliance Group LLC
FDA Compliance Group LLC offers FDA registration support, SOP development, FDA-483 and Warning letter responses, mock FDA inspections, gap analysis, and compliance training. Former FDA employees helping regulated industries achieve and 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**
- Offers expert FDA consulting services including mock audits, gap analysis, Form 483 responses, and warning letter assistance.
- Helps FDA-regulated industries maintain compliance.
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**
- Offers expert FDA consulting services including mock audits, gap analysis, Form 483 responses, and warning letter assistance.
- Helps FDA-regulated industries maintain compliance.
Additional information
FDA Compliance Group supports a diverse range 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 compliance with quality system regulations and international standards like ISO 13485. They also provide assistance with EU CE Marking and specific laboratory compliance needs such as CLIA and CAP.
Key Highlights
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Specializes in U.S. FDA and Global Regulatory Affairs for Medical Devices, 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”
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Provides support for a comprehensive list 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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Offers assistance with U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) and ISO 13485/ISO 9001 compliance.
Source
“U.S. FDA Quality System Regulation (QSR/GMP/cGMP/GLP/GCP) Regulatory Compliance ISO 13485/ISO 9001 Implementation and Regulatory Compliance”
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Provides EU Technical File Development and CE Marking assistance for MDD/IVDD compliance.
Source
“EU Technical File Development, Product CE Marking and MDD/IVDD Regulatory Compliance”
Certifications & Trust Signals
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Established expertise in FDA compliance since at least 2010.
Source
“FDA Compliance GroupCopyright © 2010-2020”
Buyer Snapshot
Best for
- Companies seeking to prepare for FDA inspections.
- Organizations needing assistance with FDA registration.
- Businesses requiring support in responding to FDA observations.
How engagement typically works
- Consultative approach leveraging former FDA expertise.
- Focus on practical preparation and remediation.
Typical deliverables
- Mock inspection reports and action plans.
- Developed or updated SOPs.
- Response strategies for FDA-483s and Warning Letters.
- Compliance training materials.
Good to know
- Best when proactive compliance measures are a priority.
- Suitable for companies operating within US FDA jurisdiction.
HQ:
New York, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD, Drugs, Dietary Supplements, Food
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
2–14 days
Pricing model:
Custom pricing
Included services:
FDA registration (establishment registration and product listing support), SOP development and documentation, FDA-483 and Warning letter responses, Mock FDA audits and inspections, Gap analysis, Inspection assistance and follow-up, Training on FDA requirements, CAPA and compliance strategy, FDA compliance master plans
Service Types:
Mock FDA Inspection
Earliest Start:
1_2_weeks
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD, Drugs
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
2–14 days
Pricing model:
Custom pricing
Included services:
FDA applications / submissions (510(k), PMA, IDE), Regulatory pathway assessment, Device classification support, Labeling review for submission, Pre-Sub / Q-Sub preparation and FDA meeting support
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, Combination product
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Former FDA investigator on team, Supports mock inspections regularly
