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.

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CMC

Newsnews

Industry plans for disruption amid Brexit uncertainty26/11/2018

With the EMA's relocation to Amsterdam showing no signs of becoming painless, the European Parliament’s health committee has signaled its intention to review the governance of agencies as an opportunity to ensure it plays an active role in future decisions. »More

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

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


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