FDAQRC
FDA Quality and Regulatory Consultants
FDAQRC provides expert consulting for FDA Quality Management System Regulation (QSR) transition and inspection readiness. They help clients navigate complex regulatory requirements.
FDAQRC, also known as FDA Quality and Regulatory Consultants, specializes in guiding companies through the transition to FDA Quality Management System Regulation (QSR) and ensuring inspection readiness. Their services are designed to help clients understand and implement the necessary quality and regulatory standards required by the FDA. Leveraging their expertise, FDAQRC assists businesses in preparing for and successfully undergoing FDA inspections. They offer insights and support to maintain compliance and operational excellence within the pharmaceutical and medical device industries. Their commitment is to support customers in achieving and sustaining high standards of quality and regulatory adherence.
About
**Who they are**
FDAQRC is a consultancy specializing in FDA Quality Management System Regulation (QSR) transition and inspection readiness for pharmaceutical, biotech, and medical device companies. They assist clients in navigating complex regulatory requirements.
**Expertise & scope**
* Expert consulting for FDA QSR transition and inspection readiness.
* Support throughout the inspection lifecycle, including mock audits and responses to FDA Form 483 observations.
* Services encompass proactive preparation, real-time assistance during inspections (on-site or remote), and reactive guidance for post-inspection responses and remediation.
* Assistance with identifying and bridging compliance gaps related to FDA, EMA, and MHRA inspections.
* Specialized guidance on crafting 483 responses to acknowledge observations and outline corrective plans.
* Remediation services to ensure long-term compliance and quality.
**Reputation / proof points**
* Team includes former FDA Investigators and Compliance Officers.
FDAQRC is a consultancy specializing in FDA Quality Management System Regulation (QSR) transition and inspection readiness for pharmaceutical, biotech, and medical device companies. They assist clients in navigating complex regulatory requirements.
**Expertise & scope**
* Expert consulting for FDA QSR transition and inspection readiness.
* Support throughout the inspection lifecycle, including mock audits and responses to FDA Form 483 observations.
* Services encompass proactive preparation, real-time assistance during inspections (on-site or remote), and reactive guidance for post-inspection responses and remediation.
* Assistance with identifying and bridging compliance gaps related to FDA, EMA, and MHRA inspections.
* Specialized guidance on crafting 483 responses to acknowledge observations and outline corrective plans.
* Remediation services to ensure long-term compliance and quality.
**Reputation / proof points**
* Team includes former FDA Investigators and Compliance Officers.
Additional information
FDAQRC emphasizes that inspections should be viewed as opportunities to ensure quality, safety, and consistency, rather than solely as threats. Their approach aims to help companies prepare for, manage, and respond to regulatory inspections effectively. They offer support for companies that need to achieve a continuous state of inspection readiness or are facing an upcoming inspection, including for-cause scenarios. Their former FDA Investigator and Compliance Officer team members leverage their experience to facilitate inspector requests and streamline the compliance demonstration process.
Key Highlights
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Team includes former FDA Investigators and Compliance Officers.
Source
“Since our team consists of former FDA Investigators and Compliance Officers, we know how to facilitate inspector requests to streamline the process and demonstrate your commitment to compliance and quality.”
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Supports companies through the entire inspection lifecycle: preparation, during, and post-inspection.
Source
“FDAQRC’s FDA, MHRA and EMA inspection readiness services support companies throughout the life cycle of an inspection, from mock audits to 483 responses.”
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Offers proactive, active, and reactive support for inspections.
Source
“Our Proactive, Active and Reactive Support; Proactive Steps: Prepare for the Inspection; Active Support: During the Inspection; Reactive Solutions: Response to Inspection Results”
Certifications & Trust Signals
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Focus on helping clients navigate complex regulatory requirements.
Source
“They help clients navigate complex regulatory requirements.”
Buyer Snapshot
Best for
- Companies preparing for FDA, EMA, or MHRA inspections.
- Organizations needing assistance with QSR transition.
- Firms requiring support in responding to inspection observations (Form 483).
How engagement typically works
- Proactive planning and preparation.
- Real-time on-site or remote support during inspections.
- Reactive guidance for post-inspection responses and remediation.
Typical deliverables
- Inspection readiness plans.
- Mock audit reports.
- Guidance on responding to FDA Form 483.
- Remediation strategies for long-term compliance.
Good to know
- Best when clients are in the pharmaceutical, biotech, or medical device sectors.
HQ:
United States, US
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Service Types:
Mock FDA Inspection
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Former FDA investigator on team, Supports mock inspections regularly
