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 for Life Sciences companies, focusing on accelerating innovation and ensuring regulatory compliance. They offer comprehensive support throughout the entire product lifecycle, from initial concept to market delivery and beyond.
**Expertise & scope**
* Full-life cycle support for pharma, MedTech, and IVD companies.
* Services span early development, manufacturing, market launch, and post-market surveillance.
* Expertise in navigating complex life sciences regulations and quality standards.
* Support for facility commissioning, equipment qualification, process validation, and tech transfer.
**Reputation / proof points**
* Specializes in regulatory affairs and UK Responsible Person services.
* Aims to accelerate the path to market for clients.
QbD Group (UKRP) is a strategic partner for Life Sciences companies, focusing on accelerating innovation and ensuring regulatory compliance. They offer comprehensive support throughout the entire product lifecycle, from initial concept to market delivery and beyond.
**Expertise & scope**
* Full-life cycle support for pharma, MedTech, and IVD companies.
* Services span early development, manufacturing, market launch, and post-market surveillance.
* Expertise in navigating complex life sciences regulations and quality standards.
* Support for facility commissioning, equipment qualification, process validation, and tech transfer.
**Reputation / proof points**
* Specializes in regulatory affairs and UK Responsible Person services.
* Aims to accelerate the path to market for clients.
Additional information
QbD Group provides scalable and flexible support designed to meet the highest quality and regulatory standards. Their services are tailored to assist clients in navigating the intricacies of life sciences regulations. They also offer industry news updates relevant to the life sciences sector, delivered directly to subscribers. Engagement with QbD Group involves leveraging their expert knowledge to ensure product compliance and market readiness.
Key Highlights
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Offers full-life cycle support for pharma, MedTech, and IVD companies.
Source
“A comprehensive range of life sciences services to support every phase of your product journey, from early development through manufacturing, market launch, and post-market surveillance.”
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Provides support for facility commissioning and equipment qualification.
Source
“From facility commissioning to equipment qualification, we provide scalable, flexible support to ensure your products meet the highest quality and regulatory standards.”
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Specializes in navigating life sciences regulations and quality.
Source
“Let our experts help you navigate the complexities of life sciences regulation and quality.”
Certifications & Trust Signals
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QbD Group is a strategic partner in Life Sciences.
Source
“QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring regulatory compliance for pharma, MedTech, and IVD companies.”
Buyer Snapshot
Best for
- Life Sciences companies (pharma, MedTech, IVD)
- Companies seeking UK Responsible Person services
- Businesses needing full-life cycle regulatory support
How engagement typically works
- Strategic partnership
- Expert-led guidance
- Full-life cycle support
Typical deliverables
- Regulatory compliance strategies
- Market launch support
- Post-market surveillance
- Validation services (process, cleaning, analytical method, sterilization)
- Tech transfer support
Good to know
- Best when requiring specialized regulatory expertise for the UK market.
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find 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
Supports MDR
true
Supports IVDR
true
Supports GB
true
Vigilance Support
true
Post Market Support
true
UK Entity Country
England
Onboarding Steps
A 3-step onboarding process is mentioned.
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