ELC Group
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Along (bio)similar lines — are biosimilars really interchangeable in the EU?
Narasimharaju SN, senior manager — regulatory affairs and Mac Kella, senior regulatory affairs executive at ELC Group assess whether biosimilars are really interchangeable in the EU. more
Jun 15, 2017 9:20 AM Opinion
Early access to medicines: EMA’s regulatory tools and support pathways
Lini Subin, director — regulatory affairs, ELC Group, highlights EMA’s regulatory tools and support pathways that are available during development. more
May 17, 2017 10:00 AM Opinion
Making it in America: Post-authorisation challenges for pharma
It is very important to work with experienced US/EU-based regulatory and market intelligence partners. more
Mar 23, 2017 9:55 AM News
Going global: How pharma is adopting to globalisation
Asia’s pharmaceutical sector - how to achieve successful globalisation Words by JinHee Kang, senior regulatory expert - biosimilars, ELC Group more
The importance of data integrity in the pharmaceutical sector
Dinesh Parsai, ELC Group examines data integrity – the FDA perspective more
Oct 28, 2016 2:15 PM News
Medical device regulation: an overview
Amit Salvi, ELC Group, provides a regulatory overview of medical devices more
Feb 22, 2016 9:28 AM Opinion
Medicine in Europe: what are the barriers?
Kushal Vyas, ELC Group, looks at barriers to generic entry in Europe more
Feb 4, 2016 11:10 AM Opinion
Capitalising pharmaceutical opportunities
Kushal Vyas, ELC Group discusses why early-stage regulatory expertise is crucial more
Nov 4, 2015 2:53 PM Opinion
Discussing vaccine programs with ELC
ELC’s Dr Parvinder Punia and Dr Siddharth Chachad discuss global and regional vaccine programmes more
Oct 5, 2015 9:26 AM Opinion
€1m influenza project marks ELC Group's entry into pharma development
Regulatory affairs services provider ELC Group has signed up for the early-stage development of a novel vaccine targeting prevention of influenza, signalling the organisation's entry into the pharmaceutical development market. more
Jun 16, 2015 11:19 AM News
ELC Group expands into product development
Regulatory affairs services provider ELC Group is expanding into the pharmaceutical development market with the creation of an extensive product portfolio targeting a range of therapeutic areas. more
Jun 11, 2015 12:00 PM News
ELC Group appoints Dr Siddharth Chachad as head of global clinical development and medical affairs
Dr Chachad is an expert in the design and execution of preclinical and clinical development programme for drug products across dosage forms and therapeutic categories. more
Aug 20, 2014 12:25 PM
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
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
