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

How recent moves by the FDA spell good news for generics in the US05/10/2017

On October 2nd 2017, the FDA held a 2-day meeting to discuss how generic drug development – especially that for complex generics – could be better streamlined. »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

Marketing Authorisation Holders, the impact of the UK’s decision to invoke Article 50 of the Treaty on European Union. How could this affect MAH’s products currently registered in the UK and EU?04/07/2017

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Latest Infographic

Signal Management +

Signal Management

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


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