Consulting

We can help and support you with the following issues:

• Labelling of Study Medication according to the EU Directive 2001/20/EC and the local requirements
• Submission of medical device and drug studies to Competent Authorities
• Submission of medical device and drug studies to Ethics Committees
• Protocol and CRF development according to the national regulations, ICH/GCP and ISO 14155:2011
• Arranging a patient insurance coverage for study patients
• Translation of study documents for example Patient Information Forms and Informed Consent Forms into German / Dutch / French / Czech/  Slovakian language
• Implementation of national requirements into Patient Information Forms and Informed Consent Forms
• Providing Inhouse Training to study teams of investigational sites and sponsors