Freyr UKRP Toolkit for Medical Device Distributors and Importers

Our UKRP Toolkit enables you to easily set up all necessary procedures to act as a UKRP
  • UKRP agreements for medical devices and IVDs
  • UK MHRA compliant procedures
  • Info guides
  • Checklists for device registration
 

UKRP Toolkit

 

12+ documents for UKRP

Step-by-step guidance for adaptation

 
 

Expert support for implementation

Dedicated customer support

 
 

Our UKRP Toolkit is the Right Solution for you

Are you a distributor or importer?

Are you located in the United Kingdom?

Are you planning to act as a UKRP for Medical Devices?

In that case, Freyr UKRP Toolkit is just the right solution for you. It would enable you to set up necessary procedures to act as a UKRP

 

 
 
 

Nisha Vempalle

Director, Medical Devices- UK

 

Your UKRP Expert

Nisha Vempalle leads Medical Devices Regulatory operations in UK and EU in Regulatory Readiness, Strategic planning and being Project delivery spearhead. She has more than 15 years of experience across Regulatory Affairs-delivering Global Innovation Projects, Regulatory strategies, leading Regulatory Projects to successful approvals and launch in Medical Devices.

Her core strength is the deep understanding of Medical Device Regulatory landscape in UK and EU regions apart from her International expertise including Asia, Africa, Middle East and South America. She has wealth of experience from her previous roles at PAGB, GlaxoSmithKline and Biocon spanning more than a decade. Nisha is a Pharmacist and holds a masters degree in Pharmaceutical sciences from Kingston University and RAC-EU & Global certified professional.

 

Our Curated Toolkit Packages

UKRP Toolkit


  • UKRP agreements
  • List of SOPs with samples
  • Operational guides
  • Account registration checklist
  • Technical document review checklist
  • Device registration checklist

£ 299

UKRP Toolkit Pro


  • UKRP agreements
  • List of SOPs with samples
  • Operational guides
  • Account registration checklist
  • Technical document review checklist
  • Device registration checklist
  • 2 hours of expert assistance on UKRP queries*

£ 399

UKRP Toolkit Pro+


  • UKRP agreements
  • Complete set of SOPs
  • Operational guides
  • Account registration checklists
  • Technical document review checklist
  • Device registration checklist
  • 5 hours of expert assistance for establishing the procedures*

£ 699

* dedicated customer support available till 180 calendar days post toolkit purchase

 

Frequently Asked Questions

It is a folder with 10 separate documents required to set up the UK Distributor/Importer/manufacturer as a UKRP.
The UKRP Services are made available from Jan 1, 2021.
Service agreement, letter of designation, review of technical documents and registration with the MHRA are some of the critical steps to be followed by a manufacturer to become a UKRP.
You can change your UKRP at any given point of time and a UKRP would notify the MHRA about termination of services.

Download Freyr Free UKRP Guide

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