Quality Management System

Need A WDA? Read Our Step By Step Guide

There has been a significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years. … Read more

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… Read more

Acorn Regulatory To Speak at RQA Ireland Forum 2019

We will be speaking at the 2019 RQA Ireland Regional Forum on May 23rd at The Kingswood Hotel in Dublin. … Read more

What Are The Benefits Of Smart Packaging In The Pharma Sector?

Much has been written about the benefits of smart packaging for the pharmaceutical sector.  The introduction of smart packaging technologies… Read more

documented

Documented Information Procedures – What You Need To Know Ahead of The Deadline

ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that… Read more

5 Steps To Obtaining A WDA - Whitepaper - Acorn Regulatory

Our WDA E-Book Is Available To Download Now

The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. … Read more

Awards Shortlist 2018

GDPR & Life Science Companies – 8 Things You Need To Know

  The introduction, on May 25th 2018, of the General Data Protection Regulation (GDPR) continues to present a particular challenge… Read more

HPRA Seminar

HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes

Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection… Read more

5 Steps To Obtain A Wholesale Distribution Authorisation Licence

The WDA process is complex.  Indeed, many companies turn to us to manage the application process on their behalf. Here,… 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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