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Year: 2015

Medical devices project awarded to Regulis

Posted at 11:14 on August 3rd, 2015 in Company news

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.

Read more “Medical devices project awarded to Regulis” →

Approval of a Broker’s Licence

Posted at 13:33 on July 31st, 2015 in Company news

Regulis recently successfully completed a project to obtain a Broker’s Licence (BL) for a new client.

Read more “Approval of a Broker’s Licence” →

Clinical Trial Application Project Awarded to Regulis

Posted at 09:41 on July 27th, 2015 in Company news

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” →

Central repository for safety reports – one year to go before mandatory use

Posted at 15:42 on June 30th, 2015 in Regulation

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” →

Phasing out of non-eCTD electronic submissions in the UK

Posted at 08:43 on April 16th, 2015 in Regulation

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” →

Another successful User Test

Posted at 13:50 on April 15th, 2015 in Trials

Regulis recently successfully completed a challenging Patient Information Leaflet readability test for a new product. Read more “Another successful User Test” →

PV Clinical Trial Project Award

Posted at 12:56 on March 26th, 2015 in Company news

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” →

FDA awards first ever Drug Shortage Assistance Award to Regulis client

Posted at 16:42 on January 30th, 2015 in Company news

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 expands its regulatory team

Posted at 16:36 on January 30th, 2015 in Company news

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” →

Recent posts

  • EMA’s Nitrosamine Implementation Oversight Group
  • New medical device rules in the Philippines
  • EC update on how to ensure a successful transition to the incoming device regulations
  • Key changes to UK amendment process for clinical trials
  • A summary of recent TGA regulatory updates

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Winner of TOPRA Support Award 2019

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