FDA Compliance Solutions
FDA Quality and Regulatory Consultants
FDAQRC provides expert regulatory compliance solutions for pharmaceutical, biotech, and medical device companies globally. They offer GxP compliance, inspection readiness, quality assurance, and staffing services.
FDA Quality and Regulatory Consultants (FDAQRC) is a premier provider of regulatory compliance solutions tailored for pharmaceutical, biotech, and medical device companies worldwide. With over a decade of experience and a global network of over 500 active consultants, FDAQRC excels in all GxP areas, addressing diverse industry needs across product life cycles. Their comprehensive service offerings include quality audits, mock inspections, gap assessments, remediation services, and staffing solutions for both employers and employees. FDAQRC specializes in connecting clients with highly qualified professionals, including former FDA employees and industry leaders, ensuring successful placements for permanent, interim, and contract roles. FDAQRC is committed to supporting clients through every stage of the regulatory compliance process. They have recently expanded their services to include Qualified Persons (QP) services for UK and EU drug releases, further enhancing client compliance and product release efficiency. With a focus on quality and science-backed processes, FDAQRC delivers optimized outcomes and maintains long-lasting client relationships.
About
**Who they are**
FDA Compliance Solutions, operating as FDAQRC, is a regulatory consulting firm with over a decade of experience, specializing in providing expert compliance solutions for the pharmaceutical, biotech, and medical device industries globally. They leverage a network of former FDA employees and industry leaders to support clients.
**Expertise & scope**
* Staffing solutions for permanent, interim, and contract roles, focusing on Quality and Regulatory professionals.
* Recruitment services for life science talent across various sectors including Pharma & Biotech (Pre-Clinical/Commercial Stage Biopharma, Big Pharma, CRO), Medical Device & Diagnostics (Class I/II/III, Digital Health), and Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device).
* Regulatory Strategy support, including CMC, Operations, Labeling/Advertising & Promotion, and pre-submission filings (IND, NDA, BLA, 510k, CTA, MAA, FDA, EMA).
* Qualified Persons (QP) services for UK and EU drug releases, assisting with product release efficiency and compliance for companies importing into or based in these regions.
* Consultant matching services, connecting clients with over 300 consultants in their network for specific project needs, including regulatory or medical writing, and technical pharmacovigilance.
* Guidance and support for individuals transitioning from the FDA to consulting roles within the biopharmaceutical industry.
**Reputation / proof points**
* Founded in 2009, with over a decade of experience.
* Assisted in completing over 6,000 life science jobs.
* Maintains a global consultant network with over 400 connections (and over 500 active consultants for QP services).
* Supports clients across more than 60 counties.
FDA Compliance Solutions, operating as FDAQRC, is a regulatory consulting firm with over a decade of experience, specializing in providing expert compliance solutions for the pharmaceutical, biotech, and medical device industries globally. They leverage a network of former FDA employees and industry leaders to support clients.
**Expertise & scope**
* Staffing solutions for permanent, interim, and contract roles, focusing on Quality and Regulatory professionals.
* Recruitment services for life science talent across various sectors including Pharma & Biotech (Pre-Clinical/Commercial Stage Biopharma, Big Pharma, CRO), Medical Device & Diagnostics (Class I/II/III, Digital Health), and Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device).
* Regulatory Strategy support, including CMC, Operations, Labeling/Advertising & Promotion, and pre-submission filings (IND, NDA, BLA, 510k, CTA, MAA, FDA, EMA).
* Qualified Persons (QP) services for UK and EU drug releases, assisting with product release efficiency and compliance for companies importing into or based in these regions.
* Consultant matching services, connecting clients with over 300 consultants in their network for specific project needs, including regulatory or medical writing, and technical pharmacovigilance.
* Guidance and support for individuals transitioning from the FDA to consulting roles within the biopharmaceutical industry.
**Reputation / proof points**
* Founded in 2009, with over a decade of experience.
* Assisted in completing over 6,000 life science jobs.
* Maintains a global consultant network with over 400 connections (and over 500 active consultants for QP services).
* Supports clients across more than 60 counties.
Additional information
FDA Compliance Solutions (FDAQRC) offers a comprehensive approach to regulatory and quality compliance, extending beyond traditional US FDA representation. Their Qualified Persons (QP) service is specifically designed for clients navigating the complexities of UK and EU drug releases, ensuring adherence to EU Good Manufacturing Practices (GMP) for product certification and market entry. This service involves rigorous vetting of experienced consultants well-versed in regional compliance requirements. For staffing needs, FDAQRC emphasizes matching highly skilled Quality and Regulatory professionals to specific organizational challenges, whether for small biotechs or large pharmaceutical companies. Their consultant network is a key asset, enabling them to provide tailored expertise for diverse projects, from regulatory writing to pharmacovigilance.
Key Highlights
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FDAQRC has over a decade of experience in placing Quality and Regulatory professionals.
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“With over a decade of experience in placing highly skilled Quality and Regulatory professionals...”
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They have assisted in completing over 6,000 life science jobs since 2009.
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“Since 2009, FDAQRC has assisted in completing over 6,000 life science jobs in over 60 counties...”
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FDAQRC offers Qualified Persons (QP) services for UK and EU drug releases.
Source
“FDA Quality and Regulatory Consultants (FDAQRC) begins Qualified Persons (QP) services.”
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Their consultant network comprises over 300 consultants for project matching.
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“We have over 300 Consultants in our network to ensure we meet your technical requirements.”
Certifications & Trust Signals
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FDAQRC leverages a global consultant network comprised of former FDA employees, European Medical professionals, QA certified, and industry leaders.
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“With a global consultant network comprised of former FDA employees, European Medical professionals, QA certified, and industry leaders...”
Buyer Snapshot
Best for
- Companies seeking specialized regulatory and quality compliance support.
- Biotech, pharmaceutical, and medical device firms needing staffing solutions.
- Organizations requiring assistance with UK/EU drug releases and compliance.
How engagement typically works
- Consultant matching for specific project needs.
- Staffing for permanent, interim, and contract roles.
- End-to-end regulatory support services.
Typical deliverables
- Qualified Person (QP) certification for UK/EU drug releases.
- Placement of Quality and Regulatory professionals.
- Regulatory strategy and submission support.
- Inspection readiness and quality assurance services.
Good to know
- Best when requiring specialized expertise in pharmaceutical, biotech, or medical device regulatory affairs.
- Ideal for companies needing to navigate both US FDA and UK/EU regulatory landscapes.
HQ:
Cedar Park, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, Drugs
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,800
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Product Type:
devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Medical Devices, Biologics, IVDs, Digital Health, Software As Medical Device
Registration Support
Implied through regulatory strategy support (e.g., 510k, NDA, BLA)
Inspection Support
Inspection readiness services are offered.
US Entity State
US
Onboarding Steps
Consultant search feature allows for quick matching of needs with consultants.
