Our regulatory affairs team manages all phases of acquiring marketing authorisation for your regulatory approvals projects, including national, MRP, DCP, centralised procedures (EMA) or variations.
We undertake the maintenance of your marketing authorisations (dossier maintenance), including updating of marketing authorisation documentation, reformatting from NTA to CTD to eCTD and processing deficiency letters.
Our clients benefit from this multidisciplinary expertise and our comprehensive regulatory project management. From its early stages, we support you with the selection, evaluation and the proposal of the best process for your products.
We provide proper ideas and concepts for expanding and securing your markets and products in the long term.
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