Licensees of Disphar products receive full and fast regulatory support throughout the process of obtaining their Marketing Authorizations. In certain cases, we may be in a position to provide you with granted MA's, thus enabling you to launch on short notice.
In case special data are required for the maintenance of your MA, Disphar can divide the costs over a “pool” of licensees, thus drastically reducing the cost per licensee.
Also, within the context of a product license agreement, Disphar can provide you with several Special RA Services that can reduce the heavy workload on your own RA department – and our services may even reduce your costs!
Presently, Disphar can offer you following Special Regulatory Services:
- Preparation of eCTD filings for MRP / DCP / National procedures. This includes, amongst others, the conversion of CTD files into eCTD and the compilation of eCTD-compliant variations.
- Management of the dossier's lifecycle, while you retain "24/7" access to your dossier by Secured Distant Access.
More Special Regulatory Services to accompany Disphar products are under development. In case you are interested to learn more, please contact Disphar’s BD Department.
