Why pharma teams are drowning in submissions and what to do about it – Part one

Regulatory affairs (RA) teams are under pressure more than ever before. Faced with a growing demand for pharmaceuticals, cumulative legislative changes and an approaching steep patent cliff, sponsors are struggling to find new ways to modernize, innovate and deliver therapeutics to market faster. . The greatest challenge isn’t just the volume of work, but the unpredictable complexity of a global regulatory landscape. Unlike demographic shifts such as the doubling of the world’s population aged 60 and above by 2050, or the $350 billion worldwide revenue loss that the industry will support through 2030 due to loss of exclusivity (LoE), regulatory change is a moving target, influenced by public health policies, technological progress and political agenda.