Marketing authorisation and CTD dossier maintenance
We carry out the maintenance of marketing authorisation dossiers with the correct combination of accuracy and efficiency: Our regulatory affairs specialists will advise you, prepare the marketing authorisation dossier for you and keep it up-to-date at all times.
Diapharm will take over every aspect of preparing, maintaining and (re)formatting the medicinal product documentation in eCTD or CTD format, as well as all related tasks:
- Preparation of the quality dossier (planning, preparing, updating, reformatting)
- Preparation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.
- Communication with regulatory authorities
- Monitoring of deadlines
- Variations
- Reformatting NtA to CTD and CTD to eCTD
In addition
to taking on the tasks related to the documentation for your dossier, Diapharm also
offers support for formal requirements placed on pharmaceutical companies. On
request we will take direct responsibility for your product, for example,
taking over functions in accordance with the German Drug Law (AMG) as qualified
persons, qualified persons responsible for pharmacovigilance, information
officers.
