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 assisting pharmaceutical, biotech, and medical device companies globally. They leverage a network of former FDA employees and industry leaders to provide specialized compliance and quality assurance services.
**Expertise & scope**
* Staffing solutions for permanent, interim, and contract roles in life sciences, focusing on Quality and Regulatory professionals.
* Recruitment expertise across various sectors including Big Pharma, CROs, Medical Device & Diagnostics (Class I/II/III, Digital Health), and Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device).
* Support for regulatory submissions and operations, including Pre-IND, NDA, BLA, 510k, CTA, MAA, and FDA/EMA processes.
* Consultant network with over 400 connections, including former FDA employees and QA certified professionals.
* Qualified Persons (QP) services for UK and EU drug releases, ensuring compliance with EU Good Manufacturing Practices (GMP).
* Guidance for transitioning from FDA roles to industry consulting, offering support in flexibility, writing styles, and organization.
* GxP Compliance Services including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Inspection Readiness and Quality Assurance Services, including audits and QMS.
**Reputation / proof points**
* Assisted in completing over 6,000 life science jobs since 2009.
* Maintains a global consultant network of over 500 active consultants.
* Offers services for clients looking to import pharmaceuticals or medical devices into the UK or EU.
FDA Compliance Solutions, operating as FDAQRC, is a regulatory consulting firm with over a decade of experience assisting pharmaceutical, biotech, and medical device companies globally. They leverage a network of former FDA employees and industry leaders to provide specialized compliance and quality assurance services.
**Expertise & scope**
* Staffing solutions for permanent, interim, and contract roles in life sciences, focusing on Quality and Regulatory professionals.
* Recruitment expertise across various sectors including Big Pharma, CROs, Medical Device & Diagnostics (Class I/II/III, Digital Health), and Biologics (Biosimilars, Small Molecule, Vaccines, Gene Therapy, CAR-T, ATMPs, Software As Medical Device).
* Support for regulatory submissions and operations, including Pre-IND, NDA, BLA, 510k, CTA, MAA, and FDA/EMA processes.
* Consultant network with over 400 connections, including former FDA employees and QA certified professionals.
* Qualified Persons (QP) services for UK and EU drug releases, ensuring compliance with EU Good Manufacturing Practices (GMP).
* Guidance for transitioning from FDA roles to industry consulting, offering support in flexibility, writing styles, and organization.
* GxP Compliance Services including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Inspection Readiness and Quality Assurance Services, including audits and QMS.
**Reputation / proof points**
* Assisted in completing over 6,000 life science jobs since 2009.
* Maintains a global consultant network of over 500 active consultants.
* Offers services for clients looking to import pharmaceuticals or medical devices into the UK or EU.
Additional information
FDA Compliance Solutions (FDAQRC) facilitates the transition of individuals from FDA roles into industry consulting, recognizing the need for flexibility and adaptability in client-facing projects. They emphasize understanding shifting writing styles and audience needs, which differ from strict FDA reporting guidelines. The firm also stresses the importance of organization for consultants managing multiple projects and deadlines. Their consultant network is designed to match specific expertise, such as regulatory or medical writing, and technical pharmacovigilance.
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”
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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”
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Maintains a global consultant network of over 400 connections.
Source
“FDAQRC has maintained a global consultant network with over 400 connections.”
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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.”
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Provides GxP Compliance Services including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
Source
“GxP Compliance Services GMP Services GCP Services GLP Services GCLP Services GVP Services CSV Services GDP Services”
Certifications & Trust Signals
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Network includes former FDA employees and European Medical professionals.
Source
“With a global consultant network comprised of former FDA employees, European Medical professionals”
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Consultants are QA certified and industry leaders.
Source
“European Medical professionals, QA certified, and industry leaders that specialize in quality and compliance projects”
Buyer Snapshot
Best for
- Companies seeking specialized Quality and Regulatory talent in life sciences.
- Organizations needing support with FDA, EMA, and UK regulatory submissions.
- Biotech and pharmaceutical companies requiring GMP compliance and product release services for UK/EU markets.
How engagement typically works
- Consultant matching based on project needs.
- Staffing for permanent, interim, and contract positions.
- Guidance and support for industry transitions.
Typical deliverables
- Recruited life science professionals.
- Qualified Persons (QP) services.
- Regulatory strategy and operations support.
- GxP compliance services.
- Inspection readiness.
Good to know
- Best when requiring specialized regulatory and quality assurance expertise.
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
Registration Support
Implied through regulatory support services.
Inspection Support
Implied through regulatory support services and inspection readiness.
US Entity State
Not explicitly stated.
Onboarding Steps
Implied through consultant search and matching process.
Recall Support
Implied through regulatory support services.
Emergency Contact24x7
Not explicitly stated.
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