TS Quality & Engineering (UKRP)
Freyr is a leading global regulatory solutions and services provider, specializing in AI-first platforms and end-to-end regulatory lifecycle management for the pharmaceutical and life sciences industries.
Freyr is a premier global regulatory solutions and services provider with a strong presence in the UKRP (United Kingdom and Republic of Ireland) market. They offer an AI-first regulatory platform, 'freya fusion', designed to manage the entire regulatory lifecycle, from submissions and labeling to intelligence and change control. With over 15 years of expertise, Freyr empowers companies to navigate complex compliance needs and achieve regulatory excellence. Their services cater to a wide range of needs, including market access, drug development, regulatory strategy, dossier authoring, post-approval management, and country-specific regulatory affairs. Freyr is recognized for its ability to deliver tailored solutions, such as staff augmentation and custom technology integrations, to accelerate regulatory operations and transform compliance into success for global bio-pharmaceutical giants and other life sciences innovators. Freyr's commitment to innovation is evident in their AI chatbot for instant regulatory answers and their strategic global presence, ensuring they are a reliable partner for businesses seeking to bring products to market compliantly and efficiently.
About
**Who they are**
TS Quality & Engineering (UKRP) is a dedicated provider of UK Responsible Person services for medical devices. They focus on ensuring that medical devices placed on the UK market meet all necessary regulatory requirements.
**Expertise & scope**
* Specializes in acting as the UK Responsible Person for manufacturers outside the UK.
* Facilitates market access for medical devices within Great Britain.
* Provides regulatory guidance and support to ensure compliance with UK regulations.
**Reputation / proof points**
* Established presence in the UK regulatory landscape.
TS Quality & Engineering (UKRP) is a dedicated provider of UK Responsible Person services for medical devices. They focus on ensuring that medical devices placed on the UK market meet all necessary regulatory requirements.
**Expertise & scope**
* Specializes in acting as the UK Responsible Person for manufacturers outside the UK.
* Facilitates market access for medical devices within Great Britain.
* Provides regulatory guidance and support to ensure compliance with UK regulations.
**Reputation / proof points**
* Established presence in the UK regulatory landscape.
Additional information
Engaging a UK Responsible Person is a critical step for manufacturers whose medical devices are intended for the UK market and who do not have a UK-based entity. TS Quality & Engineering (UKRP) acts as this essential link, ensuring that devices comply with the UK Medical Devices Regulations. Their service is designed to streamline the process of placing devices on the market, offering a point of contact for regulatory authorities within Great Britain. Buyers should consider the scope of their device portfolio and the specific regulatory pathways required when engaging their services.
Key Highlights
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Acts as the UK Responsible Person for medical device manufacturers.
Source
“TS Quality & Engineering (UKRP) is a dedicated provider of UK Responsible Person services for medical devices.”
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Facilitates market access for medical devices in Great Britain.
Source
“We are here to help you to place your medical devices on the UK market.”
Certifications & Trust Signals
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Specializes in UK regulatory compliance for medical devices.
Source
“TS Quality & Engineering (UKRP) is a dedicated provider of UK Responsible Person services for medical devices.”
Buyer Snapshot
Best for
- Manufacturers outside the UK seeking market access for medical devices.
- Companies needing a UK-based representative for regulatory compliance.
How engagement typically works
- Formal agreement for UK Responsible Person services.
- Ongoing regulatory support and liaison.
Typical deliverables
- Designation as UK Responsible Person.
- Facilitation of device registration/notification.
- Point of contact for UK regulatory authorities.
Good to know
- Best when the manufacturer has no UK establishment.
- Requires clear documentation of the medical device and its compliance status.
HQ:
London, GB
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
EUR 1,800
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
MHRA Support:
Yes
Can Be Named On Label:
Yes
Vigilance Support:
Yes
Device Classes Supported:
IVD
MHRA Portal Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The provider acts as the UK Responsible Person, requiring manufacturers to have no UK establishment. They facilitate market access and ensure compliance with UK regulations.
Device Classes Supported
All classes of medical devices
⚡ Instant booking available
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