Regulatory science to support translational development of patient-centred health technologies

Evidence generation packages: stability, reproducibility, CMC-like dossiers for bioactive-based products and delivery systems (e.g., encapsulation-enabled performance claims).
Patient-centred formulation design inputs: usability/acceptability constraints (dosage forms, sensory/consumer acceptance, compliance) mapped into regulatory evidence plans. VR would leverage its network from projects like INTEGRANO and others to gather best practices. In the consortium, VR’s tasks might include organizing regulatory workshops bringing together SMEs, and regulators to identify gaps in current regulatory processes for new technologies. VR can pilot regulatory submission case studies using one of its innovative formulations, thereby illustrating how to navigate approvals more efficiently