How to accelerate pharma regulatory success with prepopulated templates

27 Sep 2025
Pharma organizations can spend as much as $4.54B to bring a single molecule to market. The costs are only rising, while regulations are becoming more complex. This pressures organizations to manage extensive portfolios and afferent regulatory dossiers with fewer resources. When regulatory submissions take too long or are not accepted, organizations incur significant costs, from direct and tangible ones like financial costs of rework and resubmission, delayed market entry and lost revenue, increased operational costs, to more indirect costs incurred by placing the company at a competitive disadvantage, opportunity costs or, in more dramatic cases, reputation loss as a result of non-compliance and legal penalties.