With the end of 2021 fast approaching, it is worth reflecting on a year that has seen a lot of regulatory changes. For many, the first challenge was Brexit on 1st January. This included the implementation of UK national processes, and Centrally Authorised medicines transitioning to UK PLGB licences, via the MHRA Submissions Portal. For Devices, the full implementation of …
As part of the new links and growth of ESPL, a regular news letter is made to keep ESPL contacts upto date with European news. Please see below. A link has been attached if youd liked to download and share internally. ESPL-newsletter-issue10-oct2021
Kirsty is a member of the ESPL publishing team having originally joined as our Company Administrator. She supports the submissions team in preparing esubmission documents for inclusion in eCTD sequences, NeeS, etc. and uploads via agency portals.
Eleanor has recently moved into the regulatory team, having joined as a member of the ESPL publishing team straight from university, whereshe obtained a First Class honours degree in Neuroscience. Eleanor support various regulatory activities including MAA and lifecycle activities, RMPs and orphan designation applications.
ESPL as a company was established on 16 July 1996. Today we celebrate 25 years. During that time the company, that started as an electronics consultancy by Tony Erwood, and then re-focussed on Regulatory Affairs following Helen’s joining in 2000, has grown to become an employee-owned business offering expert regulatory support across a wide range of areas. We support pharmaceuticals, …
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