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Real Generics’ Regulatory News Digest For Generics – 16 July 2015

EMA has issued product-specific bioequivalence guidance for: Sirolimus 0.5 mg, 1 mg and 2 mg coated tablets and 1mg/ml oral solution Sorafenib 200mg film-coated tablets Sunitinib 12.5mg, 25mg, 37.5mg and 50mg hard capsules Tadalafil 2.5mg, 5mg, 10mg and 20mg film-coated tablets Telithromycin 400 mg film-coated tablets Voriconazole 50 mg and 200 mg tablets and 40 […]

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Draft guideline on manufacture of the finished dosage form

EMA/CHMP/QWP/245074/2015 According to EMA, This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect changes to the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply […]

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Real Generics Limited

Real Generics established in April 2015: Paddy Creed and Karen Real have established a new sister company to Real Regulatory Limited (RRL). The new company is called “Real Generics Limited” (RGL). It is driven and managed by Michelle Gafa as Managing Consultant. The purpose of the company is to provide regulatory support for generic type […]

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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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