SERVICES FOR REIMBURSEMENT


Preparation and Follow-up of Reimbursement Submission Dossiers for Human Medicinal Products and Medical Devices

Reimbursement Dossiers for Innovator Products

Our process for the preparation of the Reimbursement Dossiers of Original (innovator) Human Medicinal Products is initiated with an front-end meeting where the process, course of action and work schedule are identified.

The process continues with identification of dossier requirements, compilation of Medical and Economical data, and, if necessary, seeking the opinion of the commission members prior to the dossier preparation step. National and international literature search, establishment of specialized advisory boards, and setting up of Delphi panels where necessary.

The process is finalised upon association of the medical process with SUT (Health Implementation Notification), treatment cost analysis, constitution of the economical arguments, budget impact analysis, preparation of epidemiological and pharmaco-economical analysis and preparation of the dossier in accordance with SSA legislations after seeking final opinion of the authorities.

Follow-up of the submission, preparation of a presentation to the commission and performing necessary correspondences are also provided on demand.

Reimbursement Dossier for Generic Medicinal Products

Our process for the preparation of the Reimbursement Dossier for Generic Human Medicinal Products is initiated with a front-end meeting where the process and the working schedule are identified.

The process is finalised upon compilation of medical and economic data, identification of the dossier requirements and preparation of the dossier in accordance with the SSA legislations.

Reimbursement Dossier for Medical Devices

Our process for the preparation of the Reimbursement Dossier for Medical Devices initiated with a front-end meeting where the suitability of the product for reimbursement is evaluated and, in the case of an opinion in favor, the process and working schedule are identified.

The process is finalised upon association of the medical process with SUT (Health Implementation Notification), treatment cost analysis, constitution of the economical arguments, budget impact analysis, preparation of epidemiological and pharmaco-economical analysis and preparation of the dossier in accordance with SSA legislations after seeking final opinion of the authorities.

Follow-up of the submission, preparation of a presentation to the commission and performing necessary correspondences are also provided on demand.