QbD Group (UKRP)
QbD Group
★★★★★
4.3
/ 5
•
20 reviews
QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring regulatory compliance for pharma, MedTech, and IVD companies. They offer full-life cycle support from idea to patient.
QbD Group is a strategic partner in Life Sciences, dedicated to accelerating innovation and ensuring confident growth through regulatory compliance and operational excellence. They support over 1,200 start-ups, scale-ups, and global leaders across pharma, MedTech, and IVD sectors, solving complex challenges in quality, regulatory, clinical, and digital domains. With a team of over 600 professionals, QbD Group provides tailored, cost-effective solutions, including regulatory affairs, quality assurance, lab services, qualification & validation, clinical solutions, and software services. They help companies enter and thrive in the European market with strong GxP know-how, regulatory strategy, and clinical evidence expertise. Their approach emphasizes agile collaboration, proactive problem-solving, and delivering high-quality results efficiently. QbD Group embeds into client teams with flexibility and transparency, fostering shared success and building long-term partnerships. They offer comprehensive lifecycle support, global reach with local expertise, and a proven track record of successful projects.
About
**Who they are**
QbD Group (UKRP) is a strategic partner in Life Sciences, providing regulatory compliance for pharma, MedTech, and IVD companies. They offer full-life cycle support from idea to patient.
**Expertise & scope**
* Appointed as a UK Responsible Person (UKRP) for medical devices and IVDs, ensuring compliance with the UK MDR 2002 (as amended).
* Supports non-UK manufacturers in bringing their products to the Great Britain market.
* Acts as an experienced and independent UKRP based in London.
* Member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.
* Offers dedicated teams of international regulatory professionals with strong local knowledge for efficient registration, documentation handling, and MHRA communication.
* Provides comprehensive services across Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, Clinical Solutions, and Software Solutions.
**Reputation / proof points**
* QbD Group has over 25 years of experience in Lab Services.
* QbD Clinical has over 20 years of experience in medical device and IVD clinical development.
* QbD Group brings more than a decade of expertise and a team of +600 specialists to Qualification & Validation projects.
QbD Group (UKRP) is a strategic partner in Life Sciences, providing regulatory compliance for pharma, MedTech, and IVD companies. They offer full-life cycle support from idea to patient.
**Expertise & scope**
* Appointed as a UK Responsible Person (UKRP) for medical devices and IVDs, ensuring compliance with the UK MDR 2002 (as amended).
* Supports non-UK manufacturers in bringing their products to the Great Britain market.
* Acts as an experienced and independent UKRP based in London.
* Member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.
* Offers dedicated teams of international regulatory professionals with strong local knowledge for efficient registration, documentation handling, and MHRA communication.
* Provides comprehensive services across Regulatory Affairs, Quality Assurance, Lab Services, Qualification & Validation, Vigilance, Clinical Solutions, and Software Solutions.
**Reputation / proof points**
* QbD Group has over 25 years of experience in Lab Services.
* QbD Clinical has over 20 years of experience in medical device and IVD clinical development.
* QbD Group brings more than a decade of expertise and a team of +600 specialists to Qualification & Validation projects.
Additional information
QbD Group (UKRP) acts as a UK Responsible Person, a crucial role for manufacturers outside the UK looking to place medical devices and IVDs on the Great Britain market. This role is defined under the UK Medical Devices Regulations 2002 (as amended). As an appointed UKRP, Qarad UK Ltd., part of QbD Group, assumes responsibility for specific tasks and communicates with the MHRA on behalf of the manufacturer. Their services are designed to ensure efficient registration, accurate documentation handling, and smooth communication with regulatory authorities, allowing non-UK manufacturers to market their products with confidence. They are a member of the UK Responsible Person Association (UKRPA), underscoring their commitment to professional standards.
Key Highlights
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QbD Group (UKRP) ensures compliance with the UK MDR 2002 (as amended) for medical devices and IVDs.
Source
“QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring regulatory compliance for pharma, MedTech, and IVD companies. They offer full-life cycle support from idea to patient.”
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Acts as an experienced and independent UK Responsible Person (UKRP) based in London.
Source
“Qarad UK Ltd., part of the QbD Group, is an experienced and independent UKRP based in London.”
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Member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.
Source
“We are a member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.”
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Offers comprehensive support for bringing medical devices and IVDs to the Great Britain market.
Source
“supporting non-UK manufacturers in successfully bringing their products to the UK market.”
Certifications & Trust Signals
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QbD Group has over 25 years of experience in Lab Services.
Source
“With over 25 years of experience, QbD Group’s Lab Services provides high-quality analytical solutions tailored to the pharmaceutical industry.”
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QbD Clinical has over 20 years of experience in medical device and IVD clinical development.
Source
“With over 20 years of experience, we specialize in designing and managing clinical studies, ensuring regulatory compliance, and accelerating your path to market.”
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QbD Group brings more than a decade of expertise and a team of +600 specialists to Qualification & Validation projects.
Source
“When it comes to Qualification & Validation services, QbD Group brings more than a decade of expertise and a team of +600 specialists to every project.”
Buyer Snapshot
Best for
- Non-UK manufacturers of medical devices and IVDs seeking UK market access.
- Companies requiring a UK Responsible Person (UKRP) for regulatory compliance.
How engagement typically works
- Strategic partnership for full-life cycle support.
- Dedicated teams for efficient registration and communication.
Typical deliverables
- UK Responsible Person services.
- Regulatory compliance support for UK MDR 2002.
- MHRA communication and liaison.
- Efficient product registration and documentation handling.
Good to know
- Best when requiring a UK-based entity to act as the UK Responsible Person for medical devices and IVDs.
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
GBP 6,000
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
Yes
Device Classes Supported:
IVD
MHRA Support:
Yes
Vigilance Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Additional uk_rp Details
Device Classes Supported
All classes (implied by UK MDR 2002 support)
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The provider outlines a 3-step onboarding process for their UKRP services.
