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**
* GMP Auditing Services: Ensuring manufacturing excellence through rigorous quality oversight, including GMP Drug Auditing, GMP Medical Device Auditing, and GMP Biologics Auditing. They assist with audit and FDA inspection readiness, PAI audit preparation, and Veeva audit management support.
* GLP Auditing Services: Ensuring the integrity of laboratory data and compliance with Good Laboratory Practice standards, covering study plans, data integrity, method validation, and quality assurance unit (QAU) function.
* GCP Auditing Services: Safeguarding clinical trial integrity and patient safety with audits that ensure ethical standards and regulatory compliance, focusing on protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports.
* GCLP Auditing Services: Ensuring clinical laboratory data integrity across global trial networks, evaluating lab partners against GCLP expectations and applicable regulatory frameworks.
* CSV Auditing Services: Conducting risk-based Computerized System Validation (CSV) audits for GxP systems, covering on-prem, cloud/SaaS, and hybrid environments, and assessing validation master plans, risk assessments, IQ/OQ/PQ, change control, and vendor qualification.
* Quality System Audit Services: Evaluating quality systems against current regulations and industry best practices to uncover compliance gaps, focusing on effectiveness, implementation, and sustainability.
* Vendor and Supplier Auditing Services: Verifying the quality and compliance of external partners and supply chains against applicable regulations, quality agreements, and industry standards.
**Reputation / proof points**
* Leverages experienced industry professionals and former FDA investigators for audits.
* Provides actionable roadmaps for sustainable compliance.
* Audits are tailored to specific manufacturing environments and product types (pharmaceuticals, biologics, medical devices, combination products).
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**
* GMP Auditing Services: Ensuring manufacturing excellence through rigorous quality oversight, including GMP Drug Auditing, GMP Medical Device Auditing, and GMP Biologics Auditing. They assist with audit and FDA inspection readiness, PAI audit preparation, and Veeva audit management support.
* GLP Auditing Services: Ensuring the integrity of laboratory data and compliance with Good Laboratory Practice standards, covering study plans, data integrity, method validation, and quality assurance unit (QAU) function.
* GCP Auditing Services: Safeguarding clinical trial integrity and patient safety with audits that ensure ethical standards and regulatory compliance, focusing on protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports.
* GCLP Auditing Services: Ensuring clinical laboratory data integrity across global trial networks, evaluating lab partners against GCLP expectations and applicable regulatory frameworks.
* CSV Auditing Services: Conducting risk-based Computerized System Validation (CSV) audits for GxP systems, covering on-prem, cloud/SaaS, and hybrid environments, and assessing validation master plans, risk assessments, IQ/OQ/PQ, change control, and vendor qualification.
* Quality System Audit Services: Evaluating quality systems against current regulations and industry best practices to uncover compliance gaps, focusing on effectiveness, implementation, and sustainability.
* Vendor and Supplier Auditing Services: Verifying the quality and compliance of external partners and supply chains against applicable regulations, quality agreements, and industry standards.
**Reputation / proof points**
* Leverages experienced industry professionals and former FDA investigators for audits.
* Provides actionable roadmaps for sustainable compliance.
* Audits are tailored to specific manufacturing environments and product types (pharmaceuticals, biologics, medical devices, combination products).
Additional information
The FDA Group offers specialized auditing services across various GxP (Good Practice) guidelines, including GMP, GLP, GCP, GCLP, and CSV. They emphasize a risk-based approach, drawing on the experience of former regulators and industry professionals to identify compliance gaps and provide practical remediation steps. For organizations utilizing Veeva as their eQMS, they offer direct data entry services within the system, which can save significant time and resources. Their services are designed to help life science companies navigate complex regulatory landscapes, ensure data integrity, and maintain operational advantages.
Key Highlights
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Provides GMP, GLP, GCP, GCLP, and CSV auditing services.
Source
“Good Manufacturing Practices ensure products are produced and controlled to the appropriate quality standards while adhering to industry regulations.”
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Employs former FDA investigators and seasoned quality professionals for audits.
Source
“Our GMP auditors bring decades of experience from both sides of the inspection table, understanding not just what regulations require, but how to implement practical solutions that work on the manufacturing floor.”
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Offers specialized vendor and supplier auditing services to verify external partner compliance.
Source
“The FDA Group delivers specialized supplier and vendor audits to help life sciences companies verify the quality and compliance of their external partners and supply chain.”
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Provides Veeva eQMS data entry services in addition to auditing.
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.”
Certifications & Trust Signals
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Focuses on ensuring compliance and accelerating product development 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.”
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 robust vendor and supplier quality oversight.
How engagement typically works
- Consulting Projects
- Staff Augmentation
- FTE Recruitment
Typical deliverables
- Comprehensive audit reports with actionable roadmaps.
- Supplier qualification assessments.
- Quality system effectiveness evaluations.
- Computerized system validation documentation review.
Good to know
- Best when requiring expert-led audits with deep regulatory insight.
- Ideal for companies needing to validate manufacturing, laboratory, clinical, and IT systems.
HQ:
Westborough, US
Languages:
English
Timezones:
America/New_York
Claim 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
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
Implied through GMP and Quality System Auditing.
Onboarding Steps
Engagement models include Consulting Projects, Staff Augmentation, and FTE Recruitment. Process involves an Introductory Conversation and Resources Definition.
