RSS

ELC Group

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

27 Oct 2017 14:17 News

Pharmacovigilance is a dynamic clinical and scientific discipline that has had an important impact on the public health environment. Madalina Huruba, ELC Group, goes into the history and the necessity of an effective pharmacovigilance system more

25 Oct 2017 10:00 Opinion

As pressure to get drugs to the human clinical trial stage increases more companies are looking to outsource not only non-core functions but major areas of R&D. Here, Praveen C. Surana, ELC Group, examines outsourcing projects in more detail. more

13 Sep 2017 12:05 Opinion 1 Comments

Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. more

4 Aug 2017 15:29 News

Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape. more

31 Jul 2017 14:00 Opinion

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

15 Jun 2017 09:20 , Opinion 1 Comments

Lini Subin, director — regulatory affairs, ELC Group, highlights EMA’s regulatory tools and support pathways that are available during development. more

17 May 2017 10:00 Opinion

It is very important to work with experienced US/EU-based regulatory and market intelligence partners. more

23 Mar 2017 09:55 News

Asia’s pharmaceutical sector - how to achieve successful globalisation Words by JinHee Kang, senior regulatory expert - biosimilars, ELC Group more

News

Dinesh Parsai, ELC Group examines data integrity – the FDA perspective more

28 Oct 2016 14:15 News

Amit Salvi, ELC Group, provides a regulatory overview of medical devices more

22 Feb 2016 09:28 Opinion

Kushal Vyas, ELC Group, looks at barriers to generic entry in Europe more

4 Feb 2016 11:10 Opinion

Kushal Vyas, ELC Group discusses why early-stage regulatory expertise is crucial more

4 Nov 2015 14:53 Opinion

ELC’s Dr Parvinder Punia and Dr Siddharth Chachad discuss global and regional vaccine programmes more

5 Oct 2015 09:26 , Opinion

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

16 Jun 2015 11:19 News

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

11 Jun 2015 12:00 News

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

20 Aug 2014 12:25

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

22 Apr 2014 13:54 Regulatory Affairs Blog

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

20 Feb 2013 10:06 Technology