ICH Q12 – Where is it at and where do we want it to go?

By Tessa Fiorini-Cohen     Change is constant within the pharmaceutical industry, and requires significant resources to handle. These are further compounded by regional discrepancies and inefficiencies in post-approval change management. It is with this in mind that Q12 is being drafted – a new ICH guideline that promises to streamline post-approval CMC changes (Chemistry, […]

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Real Generics Website

A new website has been launched by Real Generics Ltd who are a consultancy firm specialising in European Regulatory Affairs and Regulatory Compliance for the generic pharmaceutical industry. The business was established in April 2015 when Karen Real (Director) and Paddy Creed (Managing Director), saw the requirement for a professional and dedicated regulatory advisory service […]

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