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ELC Group

Here, Vikash Patel, senior regulatory specialist for ELC Group, gives us an update on the regulatory developments impacting the pharma industry as a result of Brexit. more

Opinion

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... more

Opinion

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

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

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

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

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

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

, Opinion 1 Comments

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

Opinion

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

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

News

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

Opinion

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

Opinion

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

Opinion

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

, 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

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

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

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