Regulis is pleased to announce the award of a project for the CE marking of a Class III medical device consisting of a device and drug component.
Regulis recently successfully completed a project to obtain a Broker’s Licence (BL) for a new client.
Regulis is pleased to announce that it has been awarded a project to prepare and submit a French CTA for a US-based client Read more “Clinical Trial Application Project Awarded to Regulis”
The European Medicines Agency (EMA) Management Board gave the go-ahead on 12th June 2015 for the central repository for periodic safety update reports (PSURs) for medicines authorised in the European Union (EU). Read more “Central repository for safety reports – one year to go before mandatory use”
From 1st July 2015, the MHRA will no longer accept new marketing authorisation (MA) applications for decentralised procedure (DCP) in non-eCTD (NeeS) format Read more “Phasing out of non-eCTD electronic submissions in the UK”
Regulis recently successfully completed a challenging Patient Information Leaflet readability test for a new product. Read more “Another successful User Test”
Regulis are pleased to announce the award of a further two PV projects for phase I clinical trials (bioequivalence and QT studies). Read more “PV Clinical Trial Project Award”
Regulis was pleased to have assisted Clinigen Group to address the shortage of Foscavir® (foscarnet sodium) injection in the US last year. Read more “FDA awards first ever Drug Shortage Assistance Award to Regulis client”
Regulis has strengthened and expanded its regulatory team with the recent appointments of Navjeet Jolly and Silvia Stingele. Read more “Regulis expands its regulatory team”