More Featured Articles from the Acorn Regulatory Top 100
Over the course of the year we have been highlighting some of the 100 most read articles on the Acorn Regulatory website. Again, we are featuring another 10 of the top 100 most widely read articles.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersIndustry NewsMDRPharmaceuticalPharmacovigilance
How Ever-Changing Regulatory Demands Will Impact Small and Emerging Pharmaceutical and Medical Device Companies
Life science companies face considerable challenges aside from developing and launching new medicinal products and medical devices. The consistent pace of change means that companies must maintain understanding of developments in the sector. In this article, we look at some...
Case Study: How To Obtain 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...
Blog: The UK Life Science Strategy Sector Deal & The Role of Regulatory Affairs
While the UK government may not have carried out sectoral analysis of the impact of Brexit, it has developed a comprehensive industrial strategy that seeks to become the road map for the UK’s place in a global economy post Brexit. ...
New Eudravigilance System Launched by EMA
The new Eudravigilance system, aimed at improving adverse event reporting and safety monitoring, was launched today (November 22nd 2017). The new system will allow for better collaboration with the World Health Organisation (WHO) by providing access to the WHO’s Uppsala...
EU – US Mutual Recognition of Inspections Enters Operational Phase
The EU – US mutual recognition of inspections entered into its operational phase earlier this month when eight countries became the first territories outside of the USA to have their inspectorates recognised by the FDA.
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...
Acorn Regulatory Features in New ‘Irish Advantage’ Promotional Campaign
Acorn Regulatory is one of the companies featured in the new Enterprise Ireland Irish Advantage promotional campaign.
SWOT Analysis of the Amsterdam Bid for the European Medicines Agency
Amsterdam is surely one of the leading cities competing to host the European Medicines Agency. According to Dutch news sources, the bid team are working hard to ensure that the city can host EMA staff and families by working to...
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...
