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...
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 a WDA. If your company needs a WDA, we can assist you with the process in a timely and professional...
Acorn Regulatory’s Essential Guide to How-To’s & Explainers
Acorn Regulatory’s website has a wealth of guides that assist regulatory, pharmacovigilance, and clinical professionals all over the world. We consistently feature ‘how-to’ and explainer articles. This edition of the ‘Essential Guide’ looks at some of the most popular and...
Clinical Evaluation Report Requirements Under MDR
Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area. We take a look at the clinical evaluation report requirements under the MDR to be introduced in May 2021.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEileen ShortissFeatured NewsHow-To & ExplainersPharmaceutical
Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
Most Read Acorn Regulatory Publications of 2019
2019 was a busy year for our company when it came to publishing whitepapers and e-books. We looked at issues such as Wholesale Distribution Authorisations, the new medical Device Regulations, Brexit and more. Now, as the year is coming to...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMandy CashmanQuality Management SystemWDA
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 have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining...
Applying For A WDA? Follow These 5 Steps
The issue of Wholesale Distribution Authorisations has been a hot topic for companies for many years. We work with a large number of companies who utilise our Responsible Person and WDA services. In this article, we look at 5 steps...
Acorn Regulatory NewsBrexitBrian ClearyComplianceEU Authorised RepresentativeIndustry NewsMedical DevicesPharmacovigilancePublicationsRegulatory Affairs
‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
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.
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