Hopefully it is not too late to wish you a happy new year and we hope that 2018 is a successful year for you. Welcome to our first newsletter of 2018. In January 2018 newsletter we look at CEP’s and how to obtain one, requirements around mandatory eCTD and more. We also have a new whitepaper, written by a member of our expert staff, that looks at the ever changing regulatory requirements for small and medium life science companies.
The CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website. Read more here.
Now that eCTD is mandatory, you need to ensure that your dossiers are in the eCTD format. In this article we look at mandatory eCTD and what you need to do. Read more about the mandatory eCTD issue here.
We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). We are here to help you with some or all of your pharmacovigilance needs. Find out more by clicking here.
New Whitepaper: Our latest whitepaper is available to download here. It looks at the many issues that dynamic SME’s must consider in their quest to remain compliant. The whitepaper looks at issues such as the drug supply chain, IT, the FDA Quality Metrics and more.
Acorn Regulatory continues to grow. Our colleagues work on exciting pharmaceutical and medical device projects for companies around the world. Acorn Regulatory team members are some of the most experienced and knowledgeable experts in the regulatory affairs sector and we would like you to join us. Here are our latest vacancies.
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. In this blog, Brian Cleary looks at the strategy and also the role that regulatory affairs plays in the UK’s post March 2019 life science plans. Read more about the strategy here.
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