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Translation Services

This international drug manufacturing company turned to ELC Group’s team of translation experts to generate high quality product information documentation that met the exacting requirements of a Scandinavian regulatory agency and would enable the company to achieve marketing approval in a key European national market.

Customer challenge

When completing marketing submissions for a new generic product in Finland, this pharmaceutical company encountered a significant commercial challenge. With just five days to go before the expiry of its submission deadline, the company received the news that FIMEA – the regulatory agency for Finland – had rejected all of its patient information and medicine labelling as not fit for purpose.

With the clock ticking, the company urgently needed to generate and submit new text for the summary of product characteristics (SPC), patient information labelling (PIL), and labelling that met FIMEA’s stringent requirements and conformed to European Medicines Agency (EMA) guidelines.

ELC Group solution

ELC Group’s expert submissions team assessed the FIMEA feedback in readiness for generating text appropriate for the Finnish market. With just days to get the documentation submission completed and approved, the pressure was on to ensure the delivery of high quality customer and product information texts that met all local market regulatory requirements.

ELC Group brought together a team of pharmaceutical linguistic experts to ensure the documentation it generated would meet the technical and quality requirements of the Finnish assessors. As a regulatory affairs company ELC Group has over a decade of expertise in the medical, legal and marketing translation expectations of EMA assessors.

Uniquely, the ELC Group has a dedicated linguistic team of medical translators/medical writers who comprehend the precise local requirements of every European market and are skilled at ensuring consistency of forms between all medicine related documents – in other words, utilizing the same terms and phrases already approved by the EMA.

Business benefits

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