RRL News – RRL are recruiting for the role of Senior Regulatory Affairs Consultant – Ireland/UK

Job Description This position is responsible for the provision of regulatory advice to clients, preparation of critical regulatory documentation, representation of Real Regulatory and client companies at meetings and management of regulatory projects.  The successful applicant will be integral to the success of clients key projects from a Regulatory perspective. This can be a full […]

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Leslie Dowling receives Distinguished Service Award from TOPRA - present by Bob Clay. Photo courtesy of TOPRA

Real Regulatory News – Leslie Dowling receives TOPRA Distinguished Service Award

Congratulations to our colleague Leslie Dowling who recently received a Distinguished Service Award from TOPRA. Being a well-practiced multitasker,  Leslie also heads up our UK office as Managing Consultant. Having worked in regulatory affairs since 1997, mainly in human medicines, but also encompassing medical devices and veterinary medicines, Leslie is experienced in managing multiple regulatory […]

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Brexit

Notes from Brexit: HPRA-Stakeholder Engagement Event held on 31st Aug 2017

A seminar hosted in Dublin by the Health Products Regulatory Authority (HPRA) heard that a key priority for its post-Brexit strategies is to safeguard against disruption to Irish patients’ access to medicines.  The event, which was attended by over 300 representatives from the biopharma, medtech and life sciences sector, discussed the concerns of different stakeholder groups […]

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CMC Alert: Draft guideline on manufacture of the finished dosage form

EMA/CHMP/QWP/245074/2015 This draft guideline was issued for consultation by EMA between 9 July 2015 and 9 January 2016.  To date, it remains in draft. However, in our experience many of the requirements of this guideline are already being requested during product assessments by EU competent authorities. Therefore, this article serves as a reminder that, according […]

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Clinical Evaluation Reports

Clinical Evaluation Reports for Medical Devices and the new MEDDEV 2.7/1 (rev 4)

Need to create or update your Medical Device Clinical Evaluation Reports? Published in June 2016 by the European Commission, MEDDEV 2.7/1 ‘Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, the new guidance document is much more explicit on how to undertake a robust and systematic clinical evaluation, and how […]

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Steps to promotion with Real Regulatory

Real Regulatory staff promotions

We are thrilled to announce several promotions within Real Regulatory. Dorothée Fouchier has been promoted to Managing Consultant of our Dublin office. Dorothée joined the company in 2006 and during her time with us she has managed Real Regulatory’s in-company and consulting services to provide clients with the strategic advice and guidance they need for […]

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Lanuching innovation products and start-up companies with Real Regulatory guidance

Innovative Products and Start-Up Companies

Do you have an innovative product? Are you a Small or Medium Enterprise needing assistance to fully capitalise your product’s potential? The pressure on companies to raise capital and fully maximise the potential of new drug candidates is ever growing. The cost of development is ever rising and the battleground for finance is becoming increasingly […]

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Real Regulatory’s mobile friendly website

Real Regulatory’s website now mobile friendly

Real Regulatory’s website is now mobile friendly. Check out our new Blog section to keep you up to date with all the current regulatory news. Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance. We have a strong track record […]

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