Pure Global (UKRP)
Pure Global
Pure Global offers AI-powered medical device regulatory consulting and market access services in over 30 markets. They provide streamlined registration, local representation, and post-market support with transparent, flat-fee pricing starting at $2,000 USD per year.
Pure Global specializes in accelerating market entry for MedTech companies through AI-driven regulatory solutions and global representation. With over 15 offices across five continents, they offer comprehensive services including dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support. Their services are designed to navigate complex regulatory landscapes, ensuring compliance and efficient product registration in over 30 markets. Pure Global leverages AI and data tools to provide regulatory intelligence, monitor changes, and streamline compliance journeys. They offer a flat annual fee structure, starting at $2,000 USD per year for the first device, which covers a range of essential services. Key offerings include regulatory strategy, market research, classification and grouping, submission and registration, and post-market surveillance. Pure Global aims to minimize risks, reduce costs, and expedite the process of bringing medical devices to target markets worldwide.
About
**Who they are**
Pure Global (UKRP) is a global growth partner for MedTech companies, leveraging AI and data to deliver market access and regulatory consulting solutions. They combine domain expertise with technology to streamline regulatory processes.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access services across more than 30 markets globally.
* In-country regulatory representation and submission to local authorities.
* Post-market support, including modifications, renewals, and surveillance correspondence.
* Translation services for required submission documents.
* Guidance on UK Medical Devices Regulations 2002 and other relevant UK regulations through their explanation of the MHRA.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has over 15 offices on five continents, providing real-time regulatory support.
* Offers a global database and AI-powered regulatory tool for research and news.
Pure Global (UKRP) is a global growth partner for MedTech companies, leveraging AI and data to deliver market access and regulatory consulting solutions. They combine domain expertise with technology to streamline regulatory processes.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access services across more than 30 markets globally.
* In-country regulatory representation and submission to local authorities.
* Post-market support, including modifications, renewals, and surveillance correspondence.
* Translation services for required submission documents.
* Guidance on UK Medical Devices Regulations 2002 and other relevant UK regulations through their explanation of the MHRA.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has over 15 offices on five continents, providing real-time regulatory support.
* Offers a global database and AI-powered regulatory tool for research and news.
Additional information
Pure Global provides a transparent, flat-fee pricing model for their services, starting at $2,000 USD per year for the first device, excluding government fees. This inclusive annual fee covers dossier preparation, in-country representation, translation, modifications, distributor authorization, and post-market support. They emphasize accelerating market entry through their AI-driven solutions and extensive global network. Buyers can utilize their Fee Calculator for instant estimates. The company also offers a global regulatory intelligence platform for streamlined research and document searches.
Key Highlights
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Offers AI-powered dossier compilation and local representation for medical device registration.
Source
“Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee.”
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Provides services in over 30 markets globally.
Source
“We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets.”
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Transparent, flat-fee pricing starts at $2,000 USD per year for the first device (excluding government fees).
Source
“Starting at $2,000 USD per year for the first device (excluding government fees).”
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Explains the role of the MHRA as the UK's regulatory authority for medicines and medical devices.
Source
“The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the United Kingdom’s executive regulatory authority for medicines, medical devices, and blood components for transfusion.”
Certifications & Trust Signals
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Founded in 2003, the MHRA operates under the Department of Health and Social Care.
Source
“First established in 2003, the MHRA operates under the Department of Health and Social Care.”
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Pure Global has over 15 offices on five continents.
Source
“With over 15 offices on five continents, Pure Global's team of regulatory experts provide real-time, ongoing regulatory support for medical device registrations and post-market compliance.”
Buyer Snapshot
Best for
- MedTech companies seeking streamlined global market access.
- Businesses needing AI-powered regulatory consulting and local representation.
How engagement typically works
- Flat-fee annual pricing model.
- AI-driven solutions combined with expert domain knowledge.
Typical deliverables
- Dossier compilation and submission.
- In-country regulatory representation.
- Post-market surveillance support.
- Market access strategy.
Good to know
- Best when requiring support in over 30 global markets.
- Pricing excludes government and third-party fees.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $2,000 - $4,000 USD per year
Notes:
Based on publicly listed information; final fees depend on scope and number of devices. Excludes government and third-party fees.
“Starting at $2,000 USD per year for the first device (excluding government fees).”
HQ:
Boston, UK
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:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
USD 7,000
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:
Class I, Class IIa, Class IIb, Class III
MHRA Support:
Yes
Can Be Named On Label:
No
MHRA Portal Support:
No
Vigilance 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 company offers AI-powered dossier compilation and local representation, implying a structured onboarding process for registration and market access.
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