News & Insights

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about… Read more

Clinical Evaluation Reports

How To Write An Effective CER

The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the… Read more

Update on the EU Authorised Representative & Brexit

The UK is no longer a member of the European Union. However, until December 31st, 2020 it will be bound… Read more

Guidance for MAHs Covid 19

Expectations for Human Use Products During The Covid-19 Pandemic

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency… Read more

Drug Device whitepaper

Download Our Drug-Device Whitepaper

The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new… Read more

Clinical Update EBook from Acorn Regulatory

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works… Read more

 COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work.

The Competent Authorities Response to Covid-19

COVID-19 has transformed almost every aspect of our daily lives. Nevertheless,  patient safety must remain a priority. COVID-19 may force MAHs… Read more

CMC e-book from Acorn Regulatory

Download our CMC e-book Now

Acorn Regulatory’s team of CMC, pharmacovigilance, quality, clinical and medical devices experts consistently produce articles for the sector.  In the… Read more

orphan drug Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

The orphan drug pipeline continues to grow and the sector has attracted considerable interest.  We have updated this article for… Read more

Updated for 2020: A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally… Read more

MDR Delay: Regulations Delayed Until May 2021

The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic.  The European Parliament has… Read more

Pharmacovigilance Outsourcing

Outsourcing Pharmacovigilance for SME Companies

There have been significant developments in the pharmacovigilance sector since the start of the 21st century.  Keeping up with the… Read more

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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