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...
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...
Regulatory Affairs Case Study – Moving to OTC
Every day we work with some of the world’s biggest and most dynamic healthcare companies in the pharmaceutical and medical device sectors. Our team has a well deserved reputation for service excellence and their ability to successfully manage the most...
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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...
