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 manufacturers meet their regulatory obligations within the UK market.
**Expertise & scope**
* Specializes in acting as the UK Responsible Person (UKRP) for medical device manufacturers.
* Provides regulatory support for devices entering the UK market.
* Offers services to ensure compliance with UK medical device regulations.
**Reputation / proof points**
* Coverage specifically for the UK market.
TS Quality & Engineering (UKRP) is a dedicated provider of UK Responsible Person services for medical devices. They focus on ensuring manufacturers meet their regulatory obligations within the UK market.
**Expertise & scope**
* Specializes in acting as the UK Responsible Person (UKRP) for medical device manufacturers.
* Provides regulatory support for devices entering the UK market.
* Offers services to ensure compliance with UK medical device regulations.
**Reputation / proof points**
* Coverage specifically for the UK market.
Additional information
For manufacturers seeking to place medical devices on the UK market, TS Quality & Engineering (UKRP) acts as the designated UK Responsible Person. This role is crucial for ensuring that devices comply with the UK Medical Devices Regulations (UK MDR) and are correctly registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Engaging a UKRP is a mandatory requirement for overseas manufacturers without a UK-based business establishment. TS Quality & Engineering (UKRP) facilitates this by providing a local point of contact and managing essential regulatory liaison activities.
Key Highlights
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Specializes in UK Responsible Person services for medical devices.
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 the UK.
Source
“We help you to get your medical devices on the UK market.”
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Ensures compliance with UK Medical Device Regulations.
Source
“TS Quality & Engineering (UKRP) ensures that your medical devices comply with the UK Medical Devices Regulations (UK MDR).”
Certifications & Trust Signals
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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.”
Buyer Snapshot
Best for
- Overseas medical device manufacturers needing a UK Responsible Person.
- Companies seeking to comply with UK MDR requirements.
How engagement typically works
- Regulatory representation.
- Liaison with UK authorities.
Typical deliverables
- Designation as UK Responsible Person.
- Support with MHRA registration.
- Ongoing regulatory compliance assistance.
Good to know
- Best when the primary need is UK market access and regulatory representation.
HQ:
London, GB
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:
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 process involves TS Quality & Engineering (UKRP) acting as the UK Responsible Person, ensuring devices comply with UK MDR and are registered with the MHRA.
Device Classes Supported
All classes of medical devices
⚡ Instant booking available
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