our service for the pharmaceutical industry
	pharmacovigilance (Periodic Safety Update Reports, deadline monitoring)
	project planning and compilation of pharmaceutical dossiers (module 3)
	overviews and summaries (modules 2.2, 2.3, 2.4 and 2.5)
	processing of applications for marketing authorisation and answering Letters of Deficiencies (national and Mutual Recognition Procedures)
	preparation of labelling, package leaflets and summaries of product characteristics
	conformity assessment procedures for medical devices
	applications for EP-certificates of suitability (CEP) of monographed drug substances at the EDQM, Strasbourg, France
	quality documentation of non monographed drug substances
	review and monitoring on regulatory and marketing authorisation compliance of your manufacturing and testing procedures
	maintenance and supervision of your marketing authorisations
	external quality control including batch control and release