Service Centre category(ies)
Clinical Research / Clinical Trials
ICT & Electronics / Bioinformatics / Biomodelling / Biostatistics
Description of the Service Centre
This department is responsible for the whole process of registering medicines, medical devices, cosmetics and nutritional products. It monitors their life cycle and provides strategic advice and consultancy on regulatory processes.
Service Centre web address
http://www.eurotrials.com/index.php?m=12&idioma=2
Contact person's name
Catarina Ramos
Contact person's e-mail
catarina.ramos@eurotrials.com
Contact person's telephone
(+351) 21 482 54 40
Service
Medicinal Products
Available for external use?
Yes
Comments
Clinical Trials: • Revision of documents (ICF/labels/IMPD) • Translations • Preparation and submission of the Clinical Trial to CEIC/ INFARMED and CNPD: Initial submission | Substantial/ non-substantial amendments | Notification of End of Trial Mar
Service
Cosmetics and Healthcare products
Available for external use?
Yes
Comments
• Submission/notification of to INFARMED/CIAV • General Consultancy on local requirements • Revision of package material • Technical translations • MAH Transfers • Local activities for Centralised Procedure: Blue Box | National Code | Local legal st
Service
Medical Devices
Available for external use?
Yes
Comments
Support in obtaining the EC mark: • Classification of the MD • Conformity assessment • Label requirements • Clinical Research: Protocol and CRF Development | Submission/notification of clinical research to CES/INFARMED/CNPD | Monitoring | Data managem