Common Technical Document (CTD) Dossier Writing
BlueReg consultants can work in close collaboration with your experts to author, review and update your CTD (pharmaceutical, non-clinical and clinical) as required for new marketing authorization application (MAA) submissions or during the lifecycle of the medicinal product. Gap analysis or conversion from Notice to Applicants (NtA) to CTD format on multiple products according to your timelines can be performed.
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
Uncategorized - 24 April 2020
How antibody testing can help us fight COVID-19 ?
There is a high demand around the need for antibody testing and the media frenzy...
Uncategorized - 14 April 2020