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News & Insights

2019 Pharma Awards Finalist Acorn Regulatory

2019 Pharma Awards Finalist – Acorn Regulatory Shortlisted

Acorn Regulatory has been shortlisted at the 2019 Pharma Awards in the Pharma Contract Services Company of the Year category. Founded […]

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple […]

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations […]

What is KASA FDA

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  In this article we […]

No Deal Brexit Planning from Acorn Regulatory

No Deal Brexit Planning – What We Know So Far

The ongoing coverage of the UK’s moves towards leaving the European Union continues.  This is a difficult time for companies […]

What MAH's Need to Know About Outsourcing

What MAH’s Need to Know About Outsourcing

The continued growth of outsourcing of manufacturing in the pharmaceutical industry, and the use of more complicated supply chains means […]

Brexit Pharma Info for the Pharma Sector

Brexit Pharma Info: Updated for 2019

The election of Boris Johnson as the new Prime Minister of the United Kingdom has put the issue of Brexit […]

Device Vigilance System Additional Guidance: An Update from Our Devices Team

While much of the medical device industry is focused on MDR, the MDD is still in effect.  Bronwyn Kelly from […]

What Happens QPPV Post Brexit

What Will Happen To The QPPV Post Brexit?

Brexit will impact on many aspects of the life sciences sector.  One of the areas that will be most impacted […]

Join Our Team – We Are Hiring A Quality Specialist

As part of our ongoing growth, we are now recruiting for a further position.  The Quality Specialist vacancy is a […]

Clinical Trials Impacted By Brexit

Will Clinical Trials Be Impacted By Brexit?

How will clinical trials be impacted by the UK’s decision to leave the European Union? The United Kingdom’s decision to […]

Acorn Regulatory Shortlisted in 2019 CSR Awards

We have been shortlisted in the 2019 Chambers Ireland CSR Awards.  The company has been shortlisted in the SME (Small […]

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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