Gemma Robinson

How Are Changing Regulatory Demands Impacting You?

  As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory… Read more

How Will Brexit Impact UK Marketing Authorisation Holders?

The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s… Read more

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

How To Develop A Regulatory Strategy: An Overview

The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. … Read more

What’s New in Pharmacovigilance? Get Our E-Book

Our latest pharmacovigilance e-book looks at PSUR’s, key performance indicators and more.  Download the free e-book here.

Download: WDA Whitepaper – 5 Steps To Obtaining A WDA (A Wholesale Distribution Authorisation)

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

Brexit: Implications on Existing Marketing Authorisations

One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector… Read more

Type I Variation: Apparently Not So Simple

In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a… Read more

eCTD Baseline Submissions

In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.