CTD dossier maintenance

Diapharm carries out all maintenance tasks for your marketing authorisations. And we’ll do it with the correct combination of accuracy and efficiency.

Maintiaining your (e)CTD dossier

We 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

Delegate responsibility: Qualified Person services

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 as qualified person (QP), qualified person responsible for pharmacovigilance (QPPV), information officer and the like.

For more information visit www.diapharm.com