How Will The Northern Ireland Protocol Impact Pharma Companies?
How will the Northern Ireland Protocol impact companies in the pharmaceutical sector? That is a question that we have been asked many times in recent months. The issue of the Northern Ireland Protocol has continued to be a source of...
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 CMC e-book, we have compiled some of the most-read articles into a downloadable PDF. In this CMC e-book, we will...
What You Need To Know About MRP Grouped Variations
We have written extensively on the topic of variations. The topic of MRP Group Variations arises regularly in conversations with clients. A number of clients have asked us to write about the issue. Here, we have outlined an overview on...
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Download ‘Regulatory Intelligence 6’ Now
‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersRegulatory Strategy
What MAH’s Need to Know About Outsourcing
The continued growth of outsourcing of manufacturing in the pharmaceutical industry and the use of more complicated supply chains means that in certain situations the Marketing Authorisation Holder (MAH) can become very far removed from manufacturing process and products. However,...
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Download ‘Regulatory Intelligence 5’ from Acorn Regulatory
We have published our latest e-book ‘Regulatory Intelligence 5’. This edition features a number of new articles from our expert staff. The articles look at a range of issues, many of the topics were suggested by clients or visitors to...
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory Affairs
What Are The Common Variation Validation Issues? Find Out Here
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations...
Interpreting the CEP (Certificate of Suitability) Monograph
The issue of CEP’s (Certificate of Suitability) arises on a frequent basis. We have extensive experience of assisting companies in obtaining CEP’s. In this article we provide an update on what is needed for a CEP application.
Scientific Advice Meetings – Advice for Companies
Scientific Advice Meetings are an area where clients and prospective clients consistently seek our support. Our expert team has significant experience of dealing with relevant agencies for such meetings. This article looks at a number of issues related to the...
What Are The Common Mistakes With CEP’s?
The Certificate of Suitability or 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...
