TS Quality & Engineering (UKRP)
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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 provider of strategic compliance solutions for medical devices and IVDs, with offices and representatives in Switzerland, Italy, and the UK. They specialize in navigating post-Brexit regulatory requirements.
**Expertise & scope**
* Expertise in the UK post-Brexit regulatory landscape for medical devices and IVDs.
* Assistance with adapting to dual compliance pathways for UK (UKCA) and EU (CE) markets.
* Guidance on UK Responsible Person (UKRP) requirements for non-UK manufacturers.
* Services encompass navigating requirements aligned with EU MDR and IVDR.
**Reputation / proof points**
* Offices and representatives in Switzerland, Italy, and the UK.
TS Quality & Engineering (UKRP) is a provider of strategic compliance solutions for medical devices and IVDs, with offices and representatives in Switzerland, Italy, and the UK. They specialize in navigating post-Brexit regulatory requirements.
**Expertise & scope**
* Expertise in the UK post-Brexit regulatory landscape for medical devices and IVDs.
* Assistance with adapting to dual compliance pathways for UK (UKCA) and EU (CE) markets.
* Guidance on UK Responsible Person (UKRP) requirements for non-UK manufacturers.
* Services encompass navigating requirements aligned with EU MDR and IVDR.
**Reputation / proof points**
* Offices and representatives in Switzerland, Italy, and the UK.
Additional information
TS Quality & Engineering (UKRP) focuses on helping manufacturers comply with the evolving UK regulatory landscape following Brexit. They highlight that while CE-marked devices have temporary recognition, full UKCA certification will become compulsory. Manufacturers need to prepare for dual compliance pathways for both the UK and EU markets. For non-UK manufacturers without a local presence, appointing a UK Responsible Person is a key requirement mandated by the MHRA.
Key Highlights
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Provides strategic compliance solutions for post-Brexit medical device and IVD regulations.
Source
“TS Quality and Engineering, with offices and representatives in the Switzerland, Italy and the UK, provides strategic compliance solutions to navigate post-Brexit regulatory requirements for medical devices and IVDs.”
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Assists with UKCA certification, which becomes compulsory following temporary recognition of CE-marked devices.
Source
“While CE-marked devices remain temporarily recognized, full UKCA certification becomes compulsory from July 2024.”
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Offers UK Responsible Person (UKRP) services for non-UK manufacturers lacking a local presence.
Source
“Per MHRA guidelines, non-UK manufacturers lacking a local presence must appoint a UKRP to:”
Certifications & Trust Signals
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Offices and representatives in Switzerland, Italy, and the UK.
Source
“TS Quality and Engineering, with offices and representatives in the Switzerland, Italy and the UK, provides strategic compliance solutions to navigate post-Brexit regulatory requirements for medical devices and IVDs.”
Buyer Snapshot
Best for
- Non-UK medical device manufacturers needing a UK Responsible Person.
- Companies navigating post-Brexit regulatory requirements for medical devices and IVDs.
How engagement typically works
- Consultative approach to discuss needs.
- Information gathering for quotes and solutions.
Typical deliverables
- UK Responsible Person (UKRP) services.
- Strategic compliance solutions for UK market access.
- Guidance on UKCA certification requirements.
Good to know
- Best when engaging with manufacturers of medical devices and IVDs.
HQ:
London, GB
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:
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
true
Post Market Support
true
UK Entity Country
England
Onboarding Steps
Contact for quotation, fill in fields (Full Name, Email, Subject Area, Message), declare acceptance of Privacy Policy and authorization of personal data processing.
