Working with JensonR+: Case Study

JensonR+ is a trusted regulatory affairs consultant and partner. This case study outlines the support that we offered to one of our valued clients.

The Challenge

An established pharmaceutical company based in the EU launching a new drug-device combination product in Europe and the UK.

The Solution

A cross-functional team of experts from JensonR+ was assigned to prepare the submission from both a device perspective and for the UK registration of a medicine.

Co-ordinated with the original manufacturer of the device to be combined with the drug and worked together with the client and third-party manufacturer to develop the required evidence to meet the GSPRs as outlined in EU MDR 2017/745.

Liaised with notified bodies to secure Notified Body Opinion on the device.

Prepared UK dossier and submitted to the MHRA for approval.

Managed the product as an MAH via  Taw Pharma, part of the JensonR+ group of companies.

Benefits

The client was able to fill a gap in their organisational competency and was also able to access the UK market via JensonR+ and Taw Pharma services.

Faster time to market.

Solid submission reduces the likelihood of RFI or notified body non-conformances.

Reduced cost due to faster submission and no need for permanent staff to fill the gaps.

Our Regulatory Consultancy team of experts can guide your regulatory affairs strategy to help you get the most from your products in the best possible timeframe.
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Tom Wood
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