Elara Awarded European WDA
Elara Pharmaservices Europe are delighted to announce it has been successfully awarded a Wholesale Distribution Authorisation (WDA) Licence by the Irish Health Products Regulatory Authority (HPRA).
Already a holder of an MIA from the HPRA this now completes the ability for a full service offering to manufacturers who wish to import and distribute pharmaceutical products into the EEA.
Elara Pharmaservices Europe was established in 2018 as a sister company to Elara Pharmaservices Ltd in the UK, which also holds both a WDA and MIA from the UK regulatory body the MHRA, to ensure continuity of services for its Clients post Brexit.
Overarching both of the Elara Pharmaservices companies is Callisto Regulatory Consulting Ltd which together form a group of companies with the expertise and resources to provide complete services to the pharmaceutical industry including regulatory and licence applications, pharmacovigilance, QP batch release, manufacturing API site audits and provide assistance with product development and technical transfer projects.
Brexit is now certain, but the finer details are yet to be agreed however Elara together with Callisto are fully prepared for trading in both the UK and EU whatever the outcome.