PhRAse provides a wide range of services for regulatory affairs to the
pharmaceutical - human and veterinary - industry for the European market:

• Writing of chemical-pharmaceutical dossiers, quality overall summaries and expert statements for medicinal products (CTD and NtA format)
• Conversion of dossier formats into the CTD format
• Writing of IMPD's
• Writing, preparation/compilation, submission and follow-up of national (BeNeLux) and European applications for marketing authorization
• Writing, preparation/compilation, submission and follow-up of variations
• Maintenance of existing marketing authorisations
• Writing and translation of SmPC, PIL and labelling texts
• Negotiation with BeNeLux and European authorities
• Support for responses to deficiency letters
• Consultancy on R.A. strategies