Deconstructing the revised EMA guideline on manufacture of the finished dosage form

Source: Regulatory Rapporteur – Vol 14, No 9, September 2018 Authors: Tessa Fiorini Cohen, Claire Corinne Azzopardi, Michelle Gafa A recently published Regulatory Rapporteur article from our sister company Real Generics Ltd, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising […]

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 […]

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 […]