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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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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