FDA Compliance Group LLC
FDA Compliance Group LLC is a U.S.-based FDA compliance and regulatory consulting firm serving FDA-regulated companies (from startups to multinationals) in the U.S. and internationally. Led by Martina LaGrange (former FDA Field Investigator/Medical Device Specialist), the team supports medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials across the full compliance lifecycle.
EAS Consulting Group is a premier provider of regulatory compliance solutions for industries regulated by the FDA and USDA. They specialize in guiding pharmaceutical, medical device, biotechnology, and food companies through complex regulatory landscapes. Their services encompass consulting, submissions, auditing, training, and legal support, with a particular focus on acting as a US Agent for foreign firms importing FDA-regulated products into the United States. EAS assists clients with a wide range of import challenges, including prior notice, labeling accuracy, LACF registration, and FSMA supplier qualifications. They also prepare foreign firms for FDA inspections through mock inspections and help address violations found during past inspections. Furthermore, EAS provides expertise in responding to FDA Form 483 observations and ensuring compliance with 21 CFR Part 11 for electronic records and signatures, crucial for modern life science operations. With a team of experienced consultants, EAS Consulting Group helps clients navigate regulatory requirements, ensure product compliance, and facilitate market entry into the US. They are dedicated to providing expert guidance and practical solutions to meet the evolving demands of FDA regulations.
About
**Who they are**
FDA Compliance Group LLC is a U.S.-based regulatory consulting firm that supports FDA-regulated companies, from startups to multinationals, both domestically and internationally. Led by former FDA Field Investigator Martina LaGrange, the team offers expertise across medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials.
**Expertise & scope**
* Comprehensive FDA audit readiness and gap analysis, including audits of facilities, third-party facilities, vendors, suppliers, contract manufacturers, and laboratories.
* Assistance with responding to FDA Form 483 observations, aiming to prevent further regulatory actions like Warning Letters or product recalls.
* Guidance and response strategies for FDA Warning Letters, addressing violations and preventing escalated enforcement.
* Reviews of product labels and website content to ensure compliance with FDA regulations for marketing and promotions.
* Support for Serious Adverse Event Reporting (S/AER) and Medical Device Reporting (MDR) requirements.
* Technical support for law firms serving clients in FDA-regulated industries, specializing in regulatory assistance for inspections, remediation, and labeling.
* Support for FDA submissions and applications, including data and clinical study review to ensure product safety, efficacy, and readiness for submission.
**Reputation / proof points**
* Team includes former FDA employees with decades of experience.
* Serves a diverse client base, from startups to multinationals.
FDA Compliance Group LLC is a U.S.-based regulatory consulting firm that supports FDA-regulated companies, from startups to multinationals, both domestically and internationally. Led by former FDA Field Investigator Martina LaGrange, the team offers expertise across medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials.
**Expertise & scope**
* Comprehensive FDA audit readiness and gap analysis, including audits of facilities, third-party facilities, vendors, suppliers, contract manufacturers, and laboratories.
* Assistance with responding to FDA Form 483 observations, aiming to prevent further regulatory actions like Warning Letters or product recalls.
* Guidance and response strategies for FDA Warning Letters, addressing violations and preventing escalated enforcement.
* Reviews of product labels and website content to ensure compliance with FDA regulations for marketing and promotions.
* Support for Serious Adverse Event Reporting (S/AER) and Medical Device Reporting (MDR) requirements.
* Technical support for law firms serving clients in FDA-regulated industries, specializing in regulatory assistance for inspections, remediation, and labeling.
* Support for FDA submissions and applications, including data and clinical study review to ensure product safety, efficacy, and readiness for submission.
**Reputation / proof points**
* Team includes former FDA employees with decades of experience.
* Serves a diverse client base, from startups to multinationals.
Additional information
FDA Compliance Group LLC provides specialized consulting across the full compliance lifecycle for FDA-regulated industries. Their services are designed to help companies navigate complex regulatory landscapes, from initial product development through post-market surveillance. They emphasize proactive measures like mock inspections and gap analyses to identify and correct potential issues before FDA scrutiny. For companies receiving an FDA Form 483 or a Warning Letter, they offer strategic guidance to construct comprehensive responses within tight deadlines, aiming to mitigate further enforcement actions. Their expertise extends to ensuring product labeling and website content align with FDA requirements, and they offer critical support for adverse event reporting and medical device reporting.
Key Highlights
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Team includes former FDA employees with decades of experience.
Source
“Our team of FDA consultants includes former FDA employees with decades of experience”
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Supports medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials.
Source
“the team supports medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials”
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Offers assistance with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting).
Source
“we offer assistance with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting)”
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Provides technical support and expertise for law firms serving clients in FDA regulated industries.
Source
“We're happy to provide technical support and expertise for law firms that serve clients in FDA regulated industries.”
Certifications & Trust Signals
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Led by Martina LaGrange, a former FDA Field Investigator/Medical Device Specialist.
Source
“Led by Martina LaGrange (former FDA Field Investigator/Medical Device Specialist)”
Buyer Snapshot
Best for
- Companies seeking to prepare for or respond to FDA inspections and audits.
- Businesses needing assistance with FDA Form 483 responses and Warning Letter strategies.
- Firms requiring review of product labeling and website compliance.
- Manufacturers needing support with S/AER and MDR reporting.
How engagement typically works
- Consultation and direct support for regulatory challenges.
- Technical expertise for law firms serving FDA-regulated clients.
- Assembly, review, and analysis of product data and clinical studies.
Typical deliverables
- Audit reports and gap analysis findings.
- Drafted responses to FDA Form 483 and Warning Letters.
- Labeling and website compliance review reports.
- S/AER and MDR reporting guidance.
- Submission-ready documentation packages.
Good to know
- Best when proactive preparation or reactive response to FDA regulatory actions is needed.
HQ:
Broomfield, Colorado, US
Languages:
English
Timezones:
US Mountain
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
United States, International (remote)
Industries:
Medical Devices, Pharmaceuticals, Food & Beverage, Cosmetics, Dietary Supplements, Tobacco, Clinical Trials
Onboarding time:
1–14 days
Pricing model:
Custom pricing
Service Types:
US Agent Services, FDA registration/listing support, FDA submissions support (510(k), PMA, IDE, NDA/ANDA/IND), Mock FDA inspections, audits, and gap analysis, FDA-483 and Warning Letter response support, SOP development and quality system support, Labeling and website claim reviews, FDA recalls support, MDR / Serious-Adverse-Event reporting support, Food safety support (HACCP, FSVP), FDA Registration/Listing Support, Recall Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Adverse Event Reporting (MDR/AER), Regulatory Consulting, Training/Education
Specialties:
Medical devices, Drugs / pharmaceuticals, Food, Tobacco, Dietary supplements, Clinical trials / clinical studies, Cosmetics (labeling/claims review)
Expertise:
Former FDA leadership/experience (principal with FDA inspection background)
Years Of Experience:
Led by former FDA Field Investigator/Medical Device Specialist
Product Type Coverage:
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Notes:
Based in Broomfield, Colorado (P.O. Box 574). Provides FDA compliance & regulatory consulting (ex-FDA/industry consultants). NOTE: Public site does not explicitly advertise acting as the official FDA 'U.S. Agent' of record; confirm if they will serve as U.S. Agent in FDA systems.
Additional us_agent_fda Details
Product Types
Medical devices, drugs/pharma, food & tobacco, dietary supplements, clinical trials
Registration Support
Yes
Recall Support
Assistance with product recalls is implied through response to FDA 483 and Warning Letters.
Inspection Support
Audit readiness, mock FDA inspections, assistance with FDA inspections.
US Entity State
US
