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.




EU/US MRA - Brief overview and update05/10/2018

Since 2003, the EMA and the US FDA have had confidential agreements in place in order to allow for the exchange of confidential information for regulatory and scientific purposes. »More

Brexit - has the music stopped?21/08/2018

As we fast approach October, when supposedly the UK Government is to finalise and agree with the EU its Brexit strategy, we seem no closer to an actual answer as to what will happen post 30th March 2019. »More


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

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