regulatory affairs
Challenges of pharmaceutical regulation
Romulo Leon, head of global sales at Mettler-Toledo provides his take on fresh regulation challenges for pharma today. more »
Oct 22, 2014 2:14 PM Regulatory Affairs Blog
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 11:14 AM Regulatory Affairs Blog
Clinical development of inhaled products – is it really tough?
By Dr Siddharth Chachad more »
Jul 31, 2014 1:36 PM Regulatory Affairs Blog
Biosimilar evaluation in Korea
By JinHee Kang, senior regulatory expert, biosimilars more »
Jul 7, 2014 7:47 PM Opinion
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 1:54 PM Regulatory Affairs Blog
257 earn regulatory affairs certification in Autumn 2013
The Regulatory Affairs Professionals Society (RAPS) has announced that 257 regulatory professionals from around the world passed one or more Regulatory Affairs Certification (RAC) exams during the Autumn 2013 exam period. Passing one of these... more »
Mar 5, 2014 3:27 PM News
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 2:31 PM Regulatory Affairs Blog
What Is a well-established use application and when can it be used?
The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance. more »
Nov 26, 2013 11:47 AM Regulatory Affairs Blog
Overview of the EMA’s ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form’
On 4 July 2013, the European Medicines Agency (EMA) published the ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)’ for consultation. more »
Oct 16, 2013 12:42 PM Regulatory Affairs Blog
Regulatory Affairs Vs Regulatory Sciences
Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical... more »
Jun 20, 2013 11:53 AM Regulatory Affairs Blog 1 Comments
Biosimilars sector from EU and US perspectives
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013 12:10 PM Regulatory Affairs Blog
Regulatory Affairs Specialist Launches Clinical Trials Services
ELC Group has launched a new Clinical Trials service for pharmaceutical customers worldwide. The new, end-to-end service offering spans bioavailability/bioequivalence and phase I studies, phase II to phase IV and post-marketing surveillance... more »
Feb 20, 2013 10:06 AM Technology
Asia's changing regulatory environment and pharma outsourcing
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention... more »
Jan 14, 2013 2:45 PM Regulatory Affairs Blog
Extractables, leachables and QbD
Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... more »
Nov 20, 2012 5:29 PM Regulatory Affairs Blog