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 with expert practitioners.
**Expertise & scope**
* GMP Auditing Services: Ensuring manufacturing excellence through rigorous quality oversight, including drug, medical device, and biologics auditing, as well as PAI audit preparation and remediation.
* GLP Auditing Services: Verifying the integrity of laboratory data and compliance with Good Laboratory Practice standards for nonclinical safety studies.
* GCP Auditing Services: Safeguarding clinical trial integrity and patient safety by ensuring ethical standards and regulatory compliance throughout research programs.
* GCLP Auditing Services: Ensuring clinical laboratory data integrity across global trial networks, addressing data credibility, and submission delays.
* CSV Auditing Services: Conducting risk-based Computerized System Validation (CSV) audits for GxP systems across various environments (on-prem, cloud/SaaS, hybrid) to ensure compliance with FDA, EMA, and other global regulators.
* Quality System Auditing Services: Evaluating all elements of a quality system against current regulations and industry best practices to uncover compliance gaps.
* Vendor and Supplier Auditing Services: Verifying the quality and compliance of external partners and supply chain components.
**Reputation / proof points**
* Coverage includes EU and US markets.
* Services are available in English.
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 with expert practitioners.
**Expertise & scope**
* GMP Auditing Services: Ensuring manufacturing excellence through rigorous quality oversight, including drug, medical device, and biologics auditing, as well as PAI audit preparation and remediation.
* GLP Auditing Services: Verifying the integrity of laboratory data and compliance with Good Laboratory Practice standards for nonclinical safety studies.
* GCP Auditing Services: Safeguarding clinical trial integrity and patient safety by ensuring ethical standards and regulatory compliance throughout research programs.
* GCLP Auditing Services: Ensuring clinical laboratory data integrity across global trial networks, addressing data credibility, and submission delays.
* CSV Auditing Services: Conducting risk-based Computerized System Validation (CSV) audits for GxP systems across various environments (on-prem, cloud/SaaS, hybrid) to ensure compliance with FDA, EMA, and other global regulators.
* Quality System Auditing Services: Evaluating all elements of a quality system against current regulations and industry best practices to uncover compliance gaps.
* Vendor and Supplier Auditing Services: Verifying the quality and compliance of external partners and supply chain components.
**Reputation / proof points**
* Coverage includes EU and US markets.
* Services are available in English.
Additional information
The FDA Group offers specialized auditing services across various GxP (Good Practices) domains, including GMP, GLP, GCP, GCLP, and CSV. They emphasize a risk-based approach, leveraging former regulators and industry experts to identify compliance gaps and provide actionable roadmaps. For organizations utilizing Veeva as their eQMS, The FDA Group provides Veeva eQMS data entry services, which can significantly save time and attention. Their approach focuses on practical solutions that align with business objectives and ensure sustainable compliance, whether preparing for inspections, qualifying suppliers, or ensuring ongoing adherence to evolving regulatory expectations.
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 GMP, GLP, GCP, GCLP, and CSV auditing services.
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 and product development in the EU and US.
Source
“Coverage: EU, US”
Certifications & Trust Signals
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Focuses on ensuring compliance and accelerating product development.
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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Employs practitioners with 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.”
Buyer Snapshot
Best for
- Life science organizations seeking specialized RA/QA consulting.
- Companies needing to ensure compliance with GMP, GLP, GCP, GCLP, and CSV standards.
- Businesses requiring verification of vendor and supplier quality and compliance.
How engagement typically works
- Consulting Projects
- Staff Augmentation
- FTE Recruitment
Typical deliverables
- Comprehensive audit reports
- Actionable roadmaps for compliance
- Supplier qualification assessments
- Veeva eQMS data entry
Good to know
- Best when requiring expert insights from former regulators and industry professionals.
HQ:
Westborough, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
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
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
Yes
Storage Conditions Support
No
Onboarding Steps
Initial conversation, Resources definition, Engagement Model selection (Consulting Projects, Staff Augmentation, FTE Recruitment).
