Dossier of the medicinal product is a collection of documents that contains all the administrative, quality, nonclinical and clinical data on the product to be registered and marketed. The goals of the dossier are to provide relevant and adequate information to permit regulatory authorities to establish safety, efficacy, benefit-risk ratio, manufacturing processes, quality and labelling of the medicinal product.

Biomapas regulatory specialists and medical writers have detailed knowledge of the regulatory requirements and the experience necessary to support you in preparing a full eCTD-compliant dossier that is consistent, technically sound and ready for evaluation.