Assessment Methodology for Performing Regulatory Due Diligence Based on a Quantitative Approach

Abstract

Regulatory due diligence is an essential part of every assessment when it comes to mergers, transfer of regulatory licenses, co-development of products or other business activities in the pharmaceutical sector. So far, there is no uniform standard for a quality assessment of registration dossiers. The usual approach is based on a written description of the deficiencies found with eventual recommendations for corrective measures. We propose a newly developed assessment system, applied mainly to generic type of dossiers based on semi-quantitative criteria with weight factors and scores. The reasons for development of this system root in the regulatory harmonization process in Sopharma during the accession of Bulgaria to the European Union (EU). The important advantages provided by our system can also be found in the measurement of efforts put in the dossier upgrade, for example comparing the initial and final scores. The analysis of the score could provide a reliable reference point for the real value of a registration file, as well as its potential for improvement.