Operational inefficiencies due to the lack of end-to-end traceability, effort-intensive tracking and reporting across projects, and associated plans lead to submission misses and non-compliance.
Stringent regulatory compliance and submission standards by authorities have increased the risk of non-compliance and higher costs. In most cases, the existing regulatory intelligence platform is devoid of cognitive intelligence. Also, project planning is highly complex in nature and lacks self-intuitiveness.
Siloed views and gaps in regulatory submission status, lack of visibility and reuse of components, operational inefficiencies, and cumbersome program management have led pharmaceutical organizations to adopt AI/ML-driven technology solutions.