‘RQA Ireland Conference – Chain Reactions & Interactions – Review
Acorn Regulatory was the main sponsor for the 2019 RQA Ireland Conference held at the Kingswood Hotel, Citywest on May 23rd. The event, entitled ‘Chain Reactions and Interactions’ looked at the large number of developments in the pharmaceutical sector within...
Acorn Regulatory To Present At ‘Manufacturing Excellence 2019’
Experts from Acorn Regulatory will be presenting at the ‘Manufacturing Excellence 2019’ event at the Questum Centre, Clonmel, Co. Tipperary on May 29th next. This is the second time in recent years that Acorn Regulatory has presented at the event...
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. The 2019 event will focus on the theme of ‘Chain Reactions & Interactions’ and will look at the uncertainty that...
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.
The US FDA DMF Deadline: 5 Things You Need To Know
The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years. This is something that we have covered on this website on a number of occasions. The next deadline of note is that of...
Acorn Regulatory NewsBrexitIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalPharmacovigilance
Centralised Procedure Medicinal Products: Brexit Update
How will the UK’s departure from the EU impact on medicinal products for human and veterinary health? We have written an overview that, we hope, will serve as a handy guide. The Q & A document “Questions and Answers to...
Will The Updated CMC Guidelines Impact On Your Business?
Our overview will assist you in understanding the impact that the 2018 amendments will have on CMC guidelines. The updated CMC guidelines on the manufacture of the finished dosage form, CHMP/QWP/486/95, first issued in April 1996, were updated and the...
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...
Acorn Regulatory NewsComplianceIndustry NewsPharmaceuticalQuality Management SystemRegulatory Affairs
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 is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging...
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