A new addition to the JensonR+ family

Dossier module writing

For a smooth marketing authorisation application process and timely access to market, a compliant medicine dossier is necessary. The expert team at JensonR+ can take care of your dossier module writing requirements.

The following is a non-exhaustive list of the individual dossier modules we can prepare for you:

Module 1 (Administrative information and prescribing information)

Application Cover Letter
Application Form
Product information texts
Risk Management Plans

Module 2 (Overviews and summaries of Modules 3–5)

Quality Overall Summary
Non-Clinical Overview and Summaries
Clinical Overview and Summaries

Module 3 (Quality)

Drug Substance dossier modules
Drug Product dossier modules
Regional and Appendices modules

Module 4 (Non-Clinical reports)

Assistance in compiling study reports and literature references

Module 5 (Clinical study reports)

Assistance in compiling study reports and literature references

We would like to talk to you and we will listen.

We aim to understand your objectives, your aspirations and your ultimate goals.