Category: Real Generics News

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 Our recently published Regulatory Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

Read More

Congratulations to our colleague Tessa Fiorini-Cohen on graduating with Distinction

Congratulations to our colleague Tessa Fiorini-Cohen, Regulatory Affairs Consultant with Real Generics who recently completed a MSc. in Science Communication and Public Engagement (University of Edinburgh) with Distinction. The MSc. in Science Communication and Public Engagement delves into a variety of science communication and public engagement methodologies and issues. Topics covered include science policy, science […]

Read More
Malta Medicines Authority stakeholder meeting on 28th September 2016

Malta Medicines Authority stakeholder meeting – 28 September 2016

The Malta Medicines Authority (MMA) held its annual stakeholder meeting on 28th September. Two of us from Real Generics – Michelle Gafà and Tessa Fiorini Cohen – attended. The meeting was addressed by Helena Dalli, Minister for Social Dialogue, Consumer Affairs and Civil Liberties and by Anthony Serracino Inglott, Chairperson of the MMA. Various presentations […]

Read More
Recruiting regulatory specialists

Real Generics is recruiting

Real Generics, based in Swatar, Malta, provides regulatory/compliance consulting services to the generic pharmaceutical industry. The company is expanding its range of services and is looking for regulatory specialists with the appropriate qualifications. The successful candidate will provide full regulatory support in the preparation and management of marketing authorisation applications as well as lifecycle management. […]

Read More

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 […]

Read More

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 […]

Read More