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 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...
Acorn Regulatory NewsEileen ShortissMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Package Information Leaflets: An Overview
Acorn Regulatory’s consultants are package information leaflet experts. We have a team dedicated to the creation and testing of package information leaflets. Members of our team have written extensively on this website and in other industry publications about the issues...
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersPharmaceuticalRegulatory AffairsSubmissions
Repeat Use Procedure: What Are The Steps To Consider?
In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, the steps to take, and the pitfalls to avoid in...
Acorn Regulatory Case Study: Obtaining A Certificate of Suitability (CEP)
We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP...
Acorn Regulatory NewsEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can Improvements Be Made To The Readability of Package Leaflets?
We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014
Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious breach of EU regulation No. 536/2014. The European Medicines Agency describes the regulation as: The goal of Clinical Trial Regulation EU No....
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Is Well Established Use Going Out of Fashion?
The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make. One of the choices available, ‘well established use’ seems to waning in popularity as a choice amongst MAH’s. Here, we look...
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