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company Real Generics Ltd, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising […]

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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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 […]