Talking generically

This month's Regulatory Affairs blog comes to us from Chetan Javia, ELC Group’s regulatory affairs expert in India. more »

Sep 24, 2014 Regulatory Affairs Blog

Clinical development of inhaled products – is it really tough?

By Dr Siddharth Chachad more »

Jul 31, 2014 Regulatory Affairs Blog

Eight years of DCP

When the decentralised procedure (DCP) was implemented in 2005, I was employed by an agency. It was a time of great change in the EU directive and a sense of anticipation accompanied its introduction. Previous to this, there were only two... more »

May 15, 2014 Regulatory Affairs Blog

Harmonisation challenges in the EU

The EU directive, as updated in 2005, had many objectives and one of them was to ensure that the agencies harmonised medicines from one county to another. Harmonisation can be seen in several ways but is for the most part divided into two main... more »

Apr 22, 2014 Regulatory Affairs Blog

The biopharmaceutical classification system — is it accepted?

The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of... more »

Jan 31, 2014 Regulatory Affairs Blog

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