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, with a specific focus on acting as a UK Responsible Person. They offer full-life cycle support from initial concept to market delivery.

**Expertise & scope**
* Appointed by manufacturers based outside the UK to act on their behalf for placing medical devices and IVDs on the Great Britain market.
* Ensures compliance with the UK MDR 2002 (as amended).
* Facilitates communication with the Medicines and Healthcare products Regulatory Agency (MHRA).
* Offers dedicated teams of international regulatory professionals with local UK knowledge.
* Supports efficient registration and accurate documentation handling.

**Reputation / proof points**
* Qarad UK Ltd., part of QbD Group, is an experienced and independent UKRP based in London.
* Member of the UK Responsible Person Association (UKRPA), committed to professional conduct and regulatory excellence.

Additional information

QbD Group (UKRP) emphasizes a structured 3-step onboarding process for their UK Responsible Person services. They are equipped to handle the complexities of bringing medical devices and IVDs to the UK market post-Brexit, ensuring manufacturers located outside the United Kingdom can comply with the UK Medical Devices Regulations 2002. Their service includes managing communications with the MHRA and ensuring all necessary documentation is handled accurately. They position themselves as a partner that provides confidence and facilitates market access.

Key Highlights

  • Qarad UK Ltd., part of QbD Group, is an experienced and independent UKRP based in London. Source
    “Qarad UK Ltd., part of the QbD Group, is an experienced and independent UKRP based in London.”
  • 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.”
  • Ensures compliance with the UK MDR 2002 (as amended) for non-UK manufacturers. Source
    “Qabd UK Ltd., part of the QbD Group ensures your compliance with the UK MDR 2002 (as amended), supporting non-UK manufacturers in successfully bringing their products to the UK market.”

Certifications & Trust Signals

  • QbD Group is a strategic partner in Life Sciences, accelerating innovation and ensuring regulatory compliance. 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
  • Non-UK manufacturers of medical devices and IVDs needing a UK Responsible Person.
  • Companies seeking to ensure compliance with UK MDR 2002.
How engagement typically works
  • Acts as a direct representative for non-UK manufacturers.
  • Provides expert consultancy and regulatory support.
Typical deliverables
  • UK Responsible Person services.
  • MHRA communication and liaison.
  • Regulatory compliance documentation support.
  • Market access facilitation for the UK.
Good to know
  • Best when the manufacturer is based outside the United Kingdom.
HQ: London, UK
Languages: English
Timezones: Europe/London
Claim status: Listed

Services & Capabilities

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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
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
A 3-step onboarding process is mentioned.
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