Acorn Regulatory March 2018 Newsletter

In the March 2018 newsletter, we are giving you the chance to download our latest e-book and to read some of the most popular posts on our website in the last month.

As always, we welcome any thoughts that you may have on the articles that we are highlighting and you can get in touch with us by emailing

1.Using a US Dossier for a European MA Application? Here Is What You Need To Know

Over the years, we have worked with a significant number of US innovator companies and supported them getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US developed dossier for a new marketing authorisation application in Europe on behalf of a client. Read the full article here.

2.Download ‘Regulatory Intelligence Issue 2  – Our Latest E-Book

Sector specialists need to stay on top of developments in the sector.  That is why we have produced another edition of our e-book series.  ‘Regulatory Intelligence 2’ looks at a number of the critical issues in today’s regulatory sector. Download your free e-book here.

3.Preparing the Reference Safety Information for a Clinical Trial

Vanessa Hyde looks at the steps that companies need to take when preparing the reference safety information for a clinical trial.  You can read the article here.

4.Brexit Information for the Pharmaceutical Sector

Britain’s departure from the EU is 12 months away.  Many life science companies are still struggling with the uncertainty that the Brexit process has created. Have a look at the many resources that we have created on the subject of Brexit here.

5.Is Well Established Use Going Out of Fashion?

John McIntyre looks at one of the most crucial choices Marketing Authorisation Holders must make when submitting a marketing authorisation application (MAA) – the choice of legal basis.  Read the full article here.

6.Vacancy:  UK Based CMC Specialist

We have a large team of consultants based in Ireland and at sites across the world. Now we are recruiting for a Regulatory Affairs Advisor to work with our CMC team on a 6 month contract. This role can be home based (and would suit someone living in the UK or elsewhere) or you could choose to base yourself at our Irish offices.

Read more by clicking here.

7.Ever Changing Regulatory Demands

As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instill quality throughout their operations and throughout their product lifecycles. We have produced a whitepaper that looks at this topic. Download the whitepaper here

8.How To Obtain A Certificate of Suitability (CEP)

The CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website. Read more here.

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