ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade.

From the development stage through to the implementation of clinical trials, completion of product registration, and successful marketing of the product, ELC GROUP aligns itself as a strategic partner to help pharmaceutical companies achieve their healthcare goals.

CMC

CMC

Newsnews

Recent EMA Brexit Survey13/07/2018

Back in January 2018, the EMA launched a survey to all companies that held a centrally authorised product. The survey was intended to understand the level of preparedness in relation to Brexit. »More

The EMA: 100 not out15/06/2018

Usually getting to a centenary in any walk of life is cause for celebration and whilst the overall tone and soundbites from the meeting were bullish, the undertones of uncertainty are still running, mainly around the issue of Brexit. »More

Blognews

The final countdown: Transition from paper/NeeS to eCTD format submission for all regulatory activities18/09/2017

eCTD is of great interest nowadays for the pharmaceutical industries, as the EMA disposed mandatory use of eCTD format for all submissions before 2019. »More

Latest Infographic

Signal Management +

Signal Management

Flow chart to illustrate the process of signal generation, detection and evaluation


View all resources