Quality Management System

Preparing for a Remote Audit - Acorn Regulatory

How To Prepare for Remote Audits

Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by… Read more

MIA licence Manufacturers and Importation Authorisation Ireland from Acorn Regulatory

Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence  (otherwise known as an MIA Licence) for Batch Certification… Read more

Need a WDA

Do You Need A WDA? Here Is What You Need To Know

There has been an increase in the number of companies that have sought our services to assist them in obtaining… Read more

WDA in Ireland

Wholesale Distribution Authorisation: Updated Guide for 2020

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

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We… 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?  We look at… 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

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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