For all countries, PHAMOS assures compliance with ICH-GCP. The  EU Directive 2001/20/EC and related national provisions have been fully implemented into PHAMOS’ SOP. 

	Compilation of documents for submission to authorities and Ethics Committees (EC) ac. to the Directive's and national legal requirements
	Translation of patient-related documents by physicians, proof-reading, certification, back-translation if requested. Full documentation of modifications requested by authorities or ECs, e.g. in patient information. Full or key-word translation of all regulatory documents and correspondence for filing
	Request for clinical trial authorisation with national competent authorities and ECs in accordance with the EU Directive 2001/20/EC
	Follow-up of approval procedures incl. dealing with objections. National offices and native speakers facilitate a direct access to all parties involved (Competent Authorities, Ministry of Health, Ethics Committees).
	Import, interim storage and (on-demand) supply to trials sites, of medication, material and devices
	Serious Adverse Event and SUSAR expedited reporting ac. to EU Directive 2001/20/EC and national legal provisions, non-expedited periodic reporting to CA, ECs and investigators
All documents obtained from third parties will be checked for compliance with ICH-GCP requirements, completions requested if required. The sponsor will be provided with originals incl. translation into English for filing.