SERVICES: GRADOCELL PHARMA

PREPARATION AND REVIEW OF THE IMPD

We prepare Investigational Medicinal Product Dossier (IMPD) from the documentation supplied by our clients or carry out independent critical reviews at their request.

USE AUTHORISATIONS

We prepare the documentation required to apply for Use Authorisations for Advanced Therapies (covering quality, clinical and non-clinical documentation) for non-industrial products developed within clinical organisations and hospitals.

SCIENTIFIC ADVICE AEMPS/ EMA

We help our clients in the preparation of scientific advice sessions and join them during the associated meetings with the AEMPS (Agencia Española del medicamento y Productos Sanitarios) and EMA (European Medicines Agency).

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