marketing authorisation and certification
- Support and project management in marketing authorisation and certification procedures
- Compilation, revision and assessment of dossiers in the CTD and NtA format (veterinary medicinal products) for different marketing authorisation procedures
- Compilation, revision and assessment of documentations for drug substances, such as ASMF (European Active Substance Master File), US CMC Dossier or US-DMF and CEP application (European Certificate of Suitability of Monographs of the European Pharmacopoeia)
- Technical translations English-German / German-English
- All analytical work necessary for the CMC documentation (method development, validation, stability studies, establishment of reference substances, identification and qualification of impurities) as well as the compilation of the corresponding reports via our partner HWI
- Planning and supervision of method and site transfers
- Planning and supervision of process validations via our partner Sercona
- Compilation and editing of informational texts, such as package leaflet and summary of product characteristics (SPC)
- Literature searches and evaluations, literature retrieval
- Processing and and compilation of answers to deficiency letters and inquiries of authorities
- Preparation and attendance at meetings with authorities (presubmission meetings, scientific advice)
- Compilation of documentations on the proof of traditional use for the traditional registration of herbal medicinal products
- Compilation of non-clinical and clinical overviews and summaries (CTD modules 2.4 - 2.7) as well as the correponding modules 4 and 5
- Expert reports
