Answering of medical enquiries
- Answering of medical enquiries
- 24/7 hotline
- QM qualified system
- Including Adverse Events and product complaints
- Service-Portal with online accessibility if needed
- Interactive Voice Respond as required
Marketing Material - Compliance with Advertising Law
- Ensuring compliance with the Product Advertising Law
- Assessment of advertising and non-advertising materials (prescription and non-prescription products), medical devices and food supplements
- Review from a medical, regulatory and legal perspective (DE and AT)
Labeling Compliance
- Preparation and/or review of PILs and SPCs (patient information leaflets and Summary of Product Characteristics)
- Translation
- PILs for visually handicapped and blind people
- Creation and/or review of obligatory information texts (Pflichttext, Fachkurzinformation)
- Ensuring compliance with regulatory requirements
Information Officer
- If requested we take over the responsibility as QP for scientific advice / Information Officer as legally required (Germany and Austria)
Medical Affairs
- Preparation of information material, training material and presentation
- Set-up of educational material (blue hand)
- Medical Writing
- Research and online surveys
- Implementation of launch activities
- Announcements in Product Information reference lists (i.e. Red- and Yellow List)
- Product training for health care professionals, medical and scientific personnel and patients
- Conduction of compliance training for field staff and service encounters
- Data entry in the EU medicinal product dictionary (xEVMPD)
Quality Management
- Quality Management for pack material and product information
- Preparation and maintenance of corresponding operating procedures
Do you have any questions? Please feel free to contact us for further information. We are looking forward to your enquiry.
