National activities
Professional dossiers and process management
In addition to managing marketing authorisations at an international level, our experienced team in Karlsruhe has also accompanied a significant number of medicinal products (OTC and prescription-only) through the national marketing process. In this context you can capitalise on our extensive experience with electronic submission procedures, as laid down e. g. in the Austrian or German Medicinal Products Act ("AMG-EV").
What we offer:
- Preparation of dossiers for national line extensions
- Implementation of marketing authorisation processes
- Marketing authorisation renewals
- Management of graduated plan procedures (Stufenplan) and text modifications
- Variations
The role of labelling management should not be underestimated
The proper and punctual creation of product information texts (summaries of product characteristics; package leaflets; outer packaging – also in the form of mock-ups) is essential for a quick and efficient market launch, but at the same time ties up your in-house resources.
Our spectrum of services:
- Writing/revision of package leaflets and summaries of product characteristics
- Commissioning of translations, quality control
- Adaptation to QRD templates
- Adaptation to core data sheets and specimen texts
- Coordination of text implementation with production plants
- Proofreading
- Production of mock-ups
- Production and checking of production print proofs
- Inclusion of country-specific information
- Inclusion of specific customer wishes
- Creation of the product name in Braille
- Production and/or checking of mock-ups
- Submission to the regulatory authorities and follow-up