How Will Brexit Impact UK Marketing Authorisation Holders?
The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union. In this article we look at one of the main questions highlighted by the...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
How To Develop A Regulatory Strategy: An Overview
The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market its medicinal product across regions subject...
Brexit and Pharmacovigilance: Notes from the DIA QPPV Conference
Delegates from the Acorn Regulatory clinical team are attending the 11th annual DIA QPPV forum in London. One of the main talking points at the conference has been the issue of Brexit and the impact that it will have on...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitGemma RobinsonMarketing Authorisation Holders
Brexit: Implications on Existing Marketing Authorisations
One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies...
Brexit – Moving A Marketing Authorisation
The UK’s decision to leave the EU will cause considerable upheaval for holders of marketing authorisations. As the recognised Brexit experts in the regulatory affairs sector we have some advice and a number of articles to help companies that are...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
Acorn Regulatory NewsMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
Download our WDA Whitepaper
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesCase StudyMarketing Authorisation HoldersMDD DevicesMedical DevicesPharmaceuticalRegulatory Affairs
Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesPharmacovigilance
EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’
If you are a manufacturer of an IVD or a medical device, once your product is on the market, you must have an effective system for reviewing and evaluating customer complaints and product issues for any safety concerns. The European...
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