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.

Dossiers are organised into five modules in line with international guidelines. Crafting a well-written dossier is paramount to a successful marketing authorisation application. It is crucial to ensure clarity, coherence, and thorough planning across all modules prior to application. By doing this, the assessment process becomes smoother for both you, as the applicant, and the Competent Authority responsible for evaluating your application.

Optimising the accessibility of the data within your dossier can minimise the need for questions throughout the application process and can build a stronger relationship with the agency.

With a wealth of experience at its disposal, and access to clinical, non-clinical and quality experts, JensonR+ can author all modules of the dossier. Additionally, as part of the regulanet® network, we collaborate with partners worldwide, gaining valuable insights into the specific requirements of various Competent Authorities.

Below, you will find a non-exhaustive list of the individual dossier modules that we can prepare for you:

Once the dossier has been authored and is ready for submission, JensonR+ is equipped to handle the publishing and submission process on your behalf.

For further information, please refer to our eCTD publishing and Regulatory Submissions pages.

Get in touch with us to find out more