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Service Centre

Regulatory Strategy & Affairs

Eurotrials, Consultores Científicos, S.A.

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

Services

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

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