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 specializing in regulatory compliance and staffing for the life sciences industry. They leverage a global network of consultants, including former FDA employees and industry leaders.
**Expertise & scope**
* Expertise in GxP compliance, including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Services encompass inspection readiness, quality assurance, and regulatory strategy.
* Specializes in staffing solutions for permanent, interim, and contract roles within pharmaceutical, biotech, and medical device sectors.
* Offers 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.
* Provides regulatory support for various submissions including Pre-IND, NDA, BLA, 510k, CTA, and MAA.
* Assists with regulatory CMC and operations, as well as labeling and advertising.
**Reputation / proof points**
* Founded in 2009, with over a decade of experience.
* Completed over 6,000 life science jobs across more than 60 counties.
* Maintains a global consultant network with over 400 connections, including former FDA employees and QA certified professionals.
FDA Compliance Solutions, operating as FDAQRC, is a consultancy specializing in regulatory compliance and staffing for the life sciences industry. They leverage a global network of consultants, including former FDA employees and industry leaders.
**Expertise & scope**
* Expertise in GxP compliance, including GMP, GCP, GLP, GCLP, GVP, CSV, and GDP.
* Services encompass inspection readiness, quality assurance, and regulatory strategy.
* Specializes in staffing solutions for permanent, interim, and contract roles within pharmaceutical, biotech, and medical device sectors.
* Offers 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.
* Provides regulatory support for various submissions including Pre-IND, NDA, BLA, 510k, CTA, and MAA.
* Assists with regulatory CMC and operations, as well as labeling and advertising.
**Reputation / proof points**
* Founded in 2009, with over a decade of experience.
* Completed over 6,000 life science jobs across more than 60 counties.
* Maintains a global consultant network with over 400 connections, including former FDA employees and QA certified professionals.
Additional information
FDA Compliance Solutions facilitates transitions for individuals moving from FDA roles to consulting within the biopharmaceutical industry. They understand the challenges of self-employment as a consultant and provide support by matching consultants with projects aligned with their specific expertise. The company advises on key consulting skills such as flexibility in adapting to changing client deadlines and priorities, understanding diverse writing styles for different audiences, and maintaining organization when managing multiple clients and projects simultaneously. Their approach aims to support consultants in navigating the freelance landscape effectively.
Key Highlights
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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”
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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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Maintains a global consultant network of over 400 connections, including former FDA employees.
Source
“With a global consultant network comprised of former FDA employees, European Medical professionals, QA certified, and industry leaders”
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Provides a wide range of 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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Founded in 2009, indicating over 15 years of operational experience.
Source
“Since 2009, FDAQRC has assisted in completing over 6,000 life science jobs”
Buyer Snapshot
Best for
- Companies seeking specialized regulatory compliance expertise.
- Biotech, pharmaceutical, and medical device firms needing staffing solutions.
- Organizations requiring support for UK/EU drug releases.
- Former FDA professionals transitioning to consulting roles.
How engagement typically works
- Consultant matching for projects.
- Staffing for permanent, interim, and contract roles.
- Direct service provision for compliance needs.
Typical deliverables
- Regulatory compliance strategies.
- Staffing placements (Quality & Regulatory professionals).
- Qualified Person certification and release support.
- Inspection readiness and quality assurance services.
Good to know
- Best when requiring specialized life sciences regulatory and quality expertise.
HQ:
Cedar Park, US
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Find 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 a Medical Device
Registration Support
Implied through regulatory strategy and submission support.
Inspection Support
Inspection readiness services are offered.
US Entity State
US
Onboarding Steps
The website mentions a 'search feature' with 'five easy clicks' for finding consultants, suggesting a streamlined onboarding for consultant engagement.
Recall Support
Not explicitly stated.
Emergency Contact24x7
Not explicitly stated.
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