The FDA Group (EU MDR/IVDR Compliance Support)
The FDA Group, LLC
The FDA Group provides specialized RA/QA consulting and staffing for life science organizations, ensuring compliance and accelerating product development with expert practitioners.
The FDA Group offers specialized consulting and staffing services for life science organizations navigating complex regulatory landscapes. They provide access to experienced RA/QA subject matter experts who manage critical quality, regulatory, and clinical work with full accountability, supporting every stage from clinical development to commercialization. Their proprietary matching process connects clients with contracted SMEs who possess the exact skills needed for high-level strategy or hands-on execution. These experts integrate quickly, work autonomously, and are backed by a project management team and performance guarantee, ensuring measurable results and confidence in moving critical projects forward. The FDA Group's model combines the strategic insight of consultants with the practical execution of contractors. Their embedded SMEs are situationally deployed to achieve defined outcomes, supported by internal oversight, QA infrastructure, and a Total Quality Guarantee. They specialize in GMP, GLP, GCP, and GCLP auditing services, helping clients ensure manufacturing excellence, laboratory data integrity, clinical trial compliance, and overall adherence to industry regulations. With a focus on life science, The FDA Group helps companies address compliance gaps, prepare for FDA inspections, qualify suppliers, and maintain operational advantages through rigorous quality oversight led by industry veterans and former FDA investigators.
About
**Who they are**
The FDA Group (EU MDR/IVDR Compliance Support) provides specialized regulatory affairs and quality assurance consulting and staffing for life science organizations, aiming to ensure compliance and accelerate product development.
**Expertise & scope**
* Offers comprehensive auditing services across various GxP standards, including GMP, GLP, GCP, GCLP, and CSV.
* Specializes in Good Manufacturing Practices (GMP) auditing for pharmaceuticals, biologics, and medical devices, with auditors possessing experience as former FDA investigators.
* Provides Good Laboratory Practice (GLP) auditing to ensure the integrity of nonclinical safety data and compliance with regulatory expectations.
* Conducts Good Clinical Practice (GCP) audits to safeguard clinical trial integrity and patient safety, covering protocols, investigator sites, and trial master files.
* Delivers Good Clinical Laboratory Practice (GCLP) auditing to ensure clinical laboratory data integrity across global trial networks.
* Performs Computerized System Validation (CSV) auditing for GxP systems, addressing on-prem, cloud/SaaS, and hybrid environments.
* Conducts Quality System Audits to identify compliance gaps and assess the effectiveness and sustainability of quality systems.
* Offers specialized vendor and supplier auditing services to verify the quality and compliance of external partners and supply chains.
* Provides Veeva eQMS data entry services as an additional support for audit management.
**Reputation / proof points**
* Auditors include experienced industry professionals and former FDA investigators.
* Services are tailored to address specific client needs and regulatory strategies.
The FDA Group (EU MDR/IVDR Compliance Support) provides specialized regulatory affairs and quality assurance consulting and staffing for life science organizations, aiming to ensure compliance and accelerate product development.
**Expertise & scope**
* Offers comprehensive auditing services across various GxP standards, including GMP, GLP, GCP, GCLP, and CSV.
* Specializes in Good Manufacturing Practices (GMP) auditing for pharmaceuticals, biologics, and medical devices, with auditors possessing experience as former FDA investigators.
* Provides Good Laboratory Practice (GLP) auditing to ensure the integrity of nonclinical safety data and compliance with regulatory expectations.
* Conducts Good Clinical Practice (GCP) audits to safeguard clinical trial integrity and patient safety, covering protocols, investigator sites, and trial master files.
* Delivers Good Clinical Laboratory Practice (GCLP) auditing to ensure clinical laboratory data integrity across global trial networks.
* Performs Computerized System Validation (CSV) auditing for GxP systems, addressing on-prem, cloud/SaaS, and hybrid environments.
* Conducts Quality System Audits to identify compliance gaps and assess the effectiveness and sustainability of quality systems.
* Offers specialized vendor and supplier auditing services to verify the quality and compliance of external partners and supply chains.
* Provides Veeva eQMS data entry services as an additional support for audit management.
**Reputation / proof points**
* Auditors include experienced industry professionals and former FDA investigators.
* Services are tailored to address specific client needs and regulatory strategies.
Additional information
The FDA Group emphasizes a practical, actionable approach to compliance, moving beyond simple gap identification to provide roadmaps for sustainable compliance. Their auditors, many with direct experience from regulatory agencies or extensive industry backgrounds, bring a dual perspective to engagements. This allows them to not only identify compliance issues but also to offer insights into how to implement practical solutions that align with business objectives. They cater to a range of life science sectors, from pharmaceuticals and biotechnology to medical devices and combination products, adapting their audit methodologies to the unique challenges of different manufacturing environments and product types. Their services are designed to help clients navigate complex regulatory landscapes, ensuring product quality, patient safety, and successful product development.
Key Highlights
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Provides specialized RA/QA consulting and staffing for life science organizations.
Source
“The FDA Group provides specialized RA/QA consulting and staffing for life science organizations, ensuring compliance and accelerating product development with expert practitioners.”
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Offers comprehensive auditing services including GMP, GLP, GCP, GCLP, CSV, Quality System, and Vendor/Supplier Audits.
Source
“Our GMP auditing services include:; Our GLP audit teams review study plans, raw data capture, data integrity controls, method validation, animal care and housing environments, equipment calibration/maintenance, computerized system validation, and final report reconstruction.”
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Auditors include former FDA investigators and experienced industry professionals.
Source
“We ensure your manufacturing operations meet the highest quality standards with comprehensive GMP audits conducted by experienced industry professionals and former FDA investigators.”
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Supports compliance across EU and US markets.
Source
“Coverage: EU, US”
Certifications & Trust Signals
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Auditors possess direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing.
Source
“Our quality professionals bring direct experience in pharmaceutical, biotechnology, combination, and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product development.”
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Offers Veeva eQMS data entry services to save client time and attention.
Source
“Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.”
Buyer Snapshot
Best for
- Life science organizations seeking specialized RA/QA consulting.
- Companies needing comprehensive GxP auditing services.
- Organizations requiring support for EU MDR/IVDR compliance.
How engagement typically works
- Project-based consulting.
- Staff augmentation.
- FTE recruitment.
Typical deliverables
- Audit reports with actionable recommendations.
- Quality system assessments.
- Supplier qualification reports.
- Veeva eQMS data entry.
Good to know
- Best when clients require deep expertise in specific GxP areas.
- Suitable for companies preparing for regulatory inspections or needing to remediate compliance issues.
HQ:
Westborough, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Find Importer & Distributor Compliance Providers | Get Quotes
Jurisdictions:
EU, US
Countries:
US, DE, FR, NL, BE, ES, IT
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Onboarding time:
5–22 days
Pricing model:
Retainer
Starting from:
USD 5,000
Included services:
Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Deliverables:
Audit support
Role Coverage:
Importer
Training Format:
None
Additional importer_distributor_compliance Details
Role Coverage
importer, distributor, Importer, Distributor
Device Classes Supported
Class II, Class III
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Implied through auditing services for product development and manufacturing.
Storage Conditions Support
No
Onboarding Steps
Engagement models include consulting projects, staff augmentation, and FTE recruitment.
