Rubicon Technical Ltd can provide the complete end-to-end support for new product registrations.  Our team of consultants have a wealth of experience of the various registration processes for different product types to enable you to meet the complex requirements of the various regulatory authorities, in a timely manner.

Our specialist team can support with the following:  

•       Medicinal Products
•       Traditional Herbal Medicines
•           Medical Devices
•       Homeopathic products
•       Food supplement registration
•       Cosmetics

eCTD Validation, Publication and Submission

We can undertake eCTD validation and publication for all your regulatory submissions, using an advanced electronic submission management system. Furthermore, we can manage the submission of the eCTD to regulatory authorities for review and approval.  Out-sourcing eCTD publishing is a cost-effective approach that many companies utilise to avoid having to purchase their own publishing software and train employees.      

Readability Studies and Bridging Reports

Ensure that your patient information leaflets are legible, clear and easy to use with a comprehensive readability study. Rubicon Technical Ltd can design and undertake the study to produce a report which will meet the requirements of the European Commission. We can also author Bridging reports to link an existing readability study to a patient information leaflet with the same template.