Welcome to ECTD Ltd


Bringing medicine, veterinary products, cosmetics, food supplement, food, vitamins to market often requires complex procedures and documentation. ECTD Ltd. organise and streamline these tasks with your team. We asses cost and timeline of the procedure and give you controll over submission of application, product documentation, labels.

Human and veterinary medicines, cosmetics, dietary supplements, food, vitamins marketing require various administrative procedures. Occasionally complex documentation should be submitted to the competent authority. The ECTD Ltd. organizes these tasks and provide information on the expected costs and duration of the procedure. Undertake preparation of the necessary documentation and submission. The licensing process is highly regulated and requires special expertise. Provide this within the company may be costly and difficult, especially for a small number of products or lower sales volumes. Excellent solution to this problem is outsourcing the licensing tasks. The ECTD Ltd. assumes the duties to submit eCTD and compulsory license renewals during the life cycle of the product, including variations of manufacturing and product quality in cooperation with the company.



Marketing Authorisation holder shall electronically submit into the EU database (XEVMPD) information on all medicinal products for human use authorised or registered in the Union. Database access is controlled. User should provide notification of successful completion of the XEVMPD knowledge evaluation.

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Readability tests

Ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely and appropriately. It includes consultations with target patient groups for the package leaflet. Tests are in accordance with Article 65(c) of Directive 2001/83/EC, which provides for the development of guidelines concerning the legibility of particulars on the labelling and package leaflet.

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EU Individual Case Safety Report. ICSRs shall be used for reporting to the EudraVigilance database suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time. Regulation (EC) No 726/2004, Directive 2001/83/EC as amended and Directive 2001/20/EC define electronic reporting requirements to EudraVigilance of suspected adverse reactions during the development and following the marketing authorisation of medicinal products.

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