FDA Regulatory Consultants
FDAQRC offers expert regulatory compliance solutions for pharma, biotech, and medical device companies globally. They specialize in GxP, inspection readiness, and quality assurance.
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 offers comprehensive expertise across all GxP areas, addressing diverse industry needs throughout the product life cycle. Their services encompass quality audits, mock inspections, gap assessments, remediation, and specialized offerings like Qualified Persons (QP) services for UK and EU drug releases. FDAQRC also provides robust staffing solutions, connecting companies with highly skilled Quality and Regulatory professionals for permanent, interim, and contract roles. FDAQRC is committed to ensuring client compliance and product release efficiency. They leverage their extensive market knowledge and global network to source qualified candidates and consultants, facilitating a seamless recruitment and compliance process. With a new office in Northern Ireland, FDAQRC continues to expand its global footprint to better support healthcare innovation.
About
**Who they are**
FDA Regulatory Consultants provides expert regulatory compliance solutions tailored for pharmaceutical, biotech, and medical device companies worldwide. They focus on ensuring adherence to global regulatory standards.
**Expertise & scope**
* Specialization in GxP compliance, crucial for pharmaceutical and biotech industries.
* Expertise in preparing companies for FDA inspections and audits.
* Services encompass quality assurance strategies and implementation.
* Coverage extends to the United States market.
**Reputation / proof points**
* Serves global clients in the pharma, biotech, and medical device sectors.
FDA Regulatory Consultants provides expert regulatory compliance solutions tailored for pharmaceutical, biotech, and medical device companies worldwide. They focus on ensuring adherence to global regulatory standards.
**Expertise & scope**
* Specialization in GxP compliance, crucial for pharmaceutical and biotech industries.
* Expertise in preparing companies for FDA inspections and audits.
* Services encompass quality assurance strategies and implementation.
* Coverage extends to the United States market.
**Reputation / proof points**
* Serves global clients in the pharma, biotech, and medical device sectors.
Additional information
FDA Regulatory Consultants assists companies in navigating complex regulatory landscapes, particularly concerning FDA requirements. Their services are designed to support businesses aiming for robust quality assurance and successful inspection outcomes. Buyers can expect a focus on practical implementation of GxP standards and readiness for regulatory scrutiny. Engagement typically involves detailed assessment and strategic planning to meet specific compliance objectives within the pharmaceutical, biotech, and medical device industries.
Key Highlights
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Specializes in GxP, inspection readiness, and quality assurance.
Source
“They specialize in GxP, inspection readiness, and quality assurance.”
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Serves global clients in the pharmaceutical, biotechnology, and medical device sectors.
Source
“FDAQRC offers expert regulatory compliance solutions for pharma, biotech, and medical device companies globally.”
Certifications & Trust Signals
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Established provider of regulatory compliance solutions.
Source
“FDAQRC offers expert regulatory compliance solutions for pharma, biotech, and medical device companies globally.”
Buyer Snapshot
Best for
- Companies seeking GxP compliance expertise
- Businesses preparing for FDA inspections
- Pharma, biotech, and medical device firms
How engagement typically works
- Focus on expert regulatory guidance
- Solutions for quality assurance and inspection readiness
Typical deliverables
- GxP compliance strategies
- Inspection readiness plans
- Quality assurance frameworks
Good to know
- Best when requiring specialized FDA regulatory support for US market entry or compliance.
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 1,700
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Inspection Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, Inspection Support
Additional us_agent_fda Details
Product Types
Medical devices, Pharmaceuticals, Biotechnology
Registration Support
Implied through general regulatory compliance services
Recall Support
Implied through general regulatory compliance services
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
US
