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Scientific Advice Service

When an Asia-based pharmaceutical company wanted to speed time-to-market for its generic to a leading brand-name drug, it engaged ELC Group to help to get the product successfully launched in European markets on its first submission – and as the first in its market.

Customer challenge

Based in Asia, this generic pharmaceutical company had extensive in-house formulation expertise but limited regulatory resources. It knew the regulatory path for this product was complex since other companies had tried – and failed – to gain regulatory approval from European agencies. The product would need to follow an extensive guidelined path that was widely variable to the FDA development path.

With the expiration of the current patent holder’s drug sales license just a matter of weeks away, the client chose ELC Group to provide all the scientific advice and guidance it urgently needed to maximize its chances of approval and become the first generic to launch a non-infringing product  in European markets.

ELC Group solution

ELC Group immediately undertook an extensive review of the available drug data to first determine the potential validity of undergoing the submission process. Having established strong grounds were in place for success, the ELC team next prepared the client for the submission process itself and acted as the client’s representative in dealing with Europe’s regulatory bodies.

ELC Group brought together its technical and quality experts to review the client’s initial formulation and drug data and establish, in the first instance, whether it was appropriate to proceed with a possible submission. Having confirmed that the available data was rigorous and appropriate, ELC Group then mobilized its intimate knowledge of the regulatory framework and the internal workings of the regulatory agencies involved to prepare the submission strategy  on behalf of the client.

Business benefits

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