Insights

Our specialist team here at JensonR+ is experienced in regulatory affairs, product development, quality assurance, drug safety, medical information, copy approval, project management, training and market access.

Here we share insights in to our ways of thinking in this changing landscape. Any questions please talk to us, we are happy to start the conversation.

Recent posts…

From our teams…

REGULATORY NEWS
QUALITY NEWS
PHARMACOVIGILANCE NEWS
JENSONR+ COMPANY NEWS

From our Regulatory team…

MDR transition deadline for borderline devices

By |March 14th, 2024|

“Thank God I can use my MDD Class I Medical App until 2028!” This is a sentence we often hear, but realise that manufacturers are not aware of the fact that this is subject to certain conditions. Find out how we can help.

From our Quality team…

Computer Systems Validation (CSV) Part 6 – Vendors

In Part Six of this series on Computer Systems Validation, Neil Rudd looks at Suppliers, the Vendors, the Software Developers and the Hardware Providers. He looks at what the needs are in regulated industries, what we should expect and what we get.

By |May 8th, 2024|

Introducing Sharon Cullen

By |April 12th, 2024|

Earlier this year, JensonR+ welcomed Sharon Cullen, our new Qualified Person/ Quality Lead based in our office in Longford, Ireland. We had a chat with Sharon to find out a bit more about her career so far and her aspirations for the future.

From our Pharmacovigilance team…

Is it a hangover, an adverse event or a side effect?

In the world of pharmacovigilance, an adverse event is broadly any untoward medical occurrence after taking a medicinal product which does not have a causal relationship to treatment. Jim Hall looks at whether you're suffering from a hangover, an adverse event or a side effect.

By |March 18th, 2024|

MHRA GPvP symposium

By |March 7th, 2024|

Our EEA QPPV Sharon Corbett shares her key takeaways from the MHRA Good Pharmacovigilance Practice (GPvP) symposium which offered a deep dive into GPvP inspection non-compliance, metrics and trends, regulatory updates, and hot topics in pharmacovigilance.

Pharmacovigilance Audits

By |February 23rd, 2024|

Pharmacovigilance audits are essential for maintaining regulatory compliance, safeguarding patient safety, ensuring product quality, driving continuous improvement, and preserving the reputation of pharmaceutical companies.

JensonR+ company news…

Dragons Den

By |February 28th, 2024|

Everyone is familiar with the Dragons’ Den TV show. Highly passionate companies, entrepreneurs and individuals pitch to a panel of skilled marketing experts for their help and support.JensonR+ is if we can be so humble, a “Dragon”. We see opportunity and value, give guidance, share knowledge, think outside the box to problem solve and are just as committed to seeing a positive outcome as our many clients are to their products. Their success is our success.

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