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 consultancy with over a decade of experience in providing regulatory compliance and staffing solutions for the pharmaceutical, biotech, and medical device industries. They leverage a global network of consultants, including former FDA employees and industry leaders.
**Expertise & scope**
* Specializes in Quality and Regulatory professional placements for companies ranging from small biotech to large pharmaceutical organizations.
* Offers recruitment resources with market expertise across various sectors including Pharma & Biotech (Pre-Clinical/Commercial Stage Biopharma, Big Pharma, CRO), Medical Device & Diagnostics (Class I/II/III, Digital Health), Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device), and Regulatory Strategy (Regulatory CMC, Regulatory Operations, Labeling/Advertising & Promotion, Pre-IND, NDA, BLA, 510k, CTA, MAA, FDA, EMA).
* Provides staffing solutions for permanent, interim, and contract roles.
* Offers Qualified Persons (QP) services for UK and EU drug releases, assisting clients importing pharmaceuticals or medical devices into these regions.
* Supports consultants transitioning from the FDA into the biopharma industry, matching them with projects in their specific areas of expertise.
* Provides GxP Compliance Services including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Offers Inspection Readiness and Quality Assurance Services, including audits and QMS.
**Reputation / proof points**
* Founded in 2009.
* Assisted in completing over 6,000 life science jobs in over 60 counties.
* Maintains a global consultant network with over 400 connections (and over 500 active consultants for QP services).
FDA Compliance Solutions, operating as FDAQRC, is a consultancy with over a decade of experience in providing regulatory compliance and staffing solutions for the pharmaceutical, biotech, and medical device industries. They leverage a global network of consultants, including former FDA employees and industry leaders.
**Expertise & scope**
* Specializes in Quality and Regulatory professional placements for companies ranging from small biotech to large pharmaceutical organizations.
* Offers recruitment resources with market expertise across various sectors including Pharma & Biotech (Pre-Clinical/Commercial Stage Biopharma, Big Pharma, CRO), Medical Device & Diagnostics (Class I/II/III, Digital Health), Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device), and Regulatory Strategy (Regulatory CMC, Regulatory Operations, Labeling/Advertising & Promotion, Pre-IND, NDA, BLA, 510k, CTA, MAA, FDA, EMA).
* Provides staffing solutions for permanent, interim, and contract roles.
* Offers Qualified Persons (QP) services for UK and EU drug releases, assisting clients importing pharmaceuticals or medical devices into these regions.
* Supports consultants transitioning from the FDA into the biopharma industry, matching them with projects in their specific areas of expertise.
* Provides GxP Compliance Services including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Offers Inspection Readiness and Quality Assurance Services, including audits and QMS.
**Reputation / proof points**
* Founded in 2009.
* Assisted in completing over 6,000 life science jobs in over 60 counties.
* Maintains a global consultant network with over 400 connections (and over 500 active consultants for QP services).
Additional information
FDA Compliance Solutions (FDAQRC) facilitates the transition for individuals moving from FDA roles to consulting within the biopharmaceutical industry. They emphasize the importance of flexibility, understanding shifting writing styles and audiences, and maintaining organization when managing multiple clients and projects. Their services are designed to support consultants by matching them with projects aligned with their specific expertise, offering a pathway to a more independent and flexible career.
Key Highlights
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Over a decade of experience in placing Quality and Regulatory professionals.
Source
“With over a decade of experience in placing highly skilled Quality and Regulatory professionals across small clinical stage biotech’s through to big pharma”
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Assisted in completing over 6,000 life science jobs since 2009.
Source
“Since 2009, FDAQRC has assisted in completing over 6,000 life science jobs in over 60 counties”
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Global consultant network includes former FDA employees and industry leaders.
Source
“With a global consultant network comprised of former FDA employees, European Medical professionals, QA certified, and industry leaders”
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Offers Qualified Persons (QP) services for UK and EU drug releases.
Source
“FDA Quality and Regulatory Consultants (FDAQRC) begins Qualified Persons (QP) services. “We are adding this service to our product line to enhance client compliance and assist in product release efficiency for UK and EU drug releases”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking specialized regulatory and quality professionals.
- Biotech, pharmaceutical, and medical device firms needing staffing support.
- Organizations requiring assistance with UK/EU drug releases.
- Former FDA employees transitioning to consulting roles.
How engagement typically works
- Consultant matching for permanent, interim, and contract roles.
- Project-based support for regulatory compliance.
- Staff augmentation for quality and regulatory functions.
Typical deliverables
- Recruited life science talent.
- Qualified Persons (QP) certification for UK/EU imports.
- GxP compliance support.
- Inspection readiness.
- Quality assurance audits.
Good to know
- Best when requiring specialized expertise in life sciences regulatory affairs and quality assurance.
HQ:
Cedar Park, US
Languages:
English
Timezones:
America/New_York
Claim 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
Time Zone Coverage:
Eastern Standard Time, Central Standard Time, Central European Time
Product Type:
drugs, devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Inspection Support:
Yes
Additional us_agent_fda Details
Product Types
Pharmaceuticals, Medical Devices, Biologics, IVDs, Digital Health, Software As Medical Device
Registration Support
Implied through regulatory services, but not explicitly stated as a standalone service.
Inspection Support
Inspection readiness services are offered.
US Entity State
Not explicitly stated.
Onboarding Steps
The website mentions a 'search feature' for consultants and a process for matching needs with ideal consultants, implying a structured engagement.
Recall Support
Not explicitly stated.
Emergency Contact24x7
Not explicitly stated.
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