Using a US Dossier for a European MA Application? Here Is What You Need To Know
Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the...
How Are Changing Regulatory Demands Impacting You?
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In...
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HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes
Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection and advertising compliance programmes that was held at the Hilton Dublin on November 27th 2017.
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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...
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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.
Brexit Whitepaper No. 4 – What’s Next? – Download It Here
In our 4th Acorn Regulatory Brexit whitepaper entitled ‘What’s Next’ we focus on the results of our extensive Brexit survey. We look at our survey respondents favoured locations for the EMA, the future of the MHRA and much more.
Do Patient Groups Have A Role In Package Leaflet Creation?
What role do target patient groups have in the creation of a package leaflet? We look at the issue and the directives concerning package leaflets in our blog.
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Download our WDA Whitepaper
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf.
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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...
Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
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