We provide project teams and PMO leaders with deep industry expertise and decades of experience accelerating delivery of key initiatives, from strategy to execution.
Our project teams and SMEs support clinical development (e.g. clinical trial physicians and clinical leaders building protocols) and clinical operations (e.g. study management and CRAs) to help drive even the most complex clinical studies.
We provide subject matter experts and cross-functional core team leadership for stage-gated development processes to support R&D from concept to commercialization.
We’ve helped clients respond to regulatory citations, remediate issues raised in 483 warning letters, and design and manage CAPA workstreams. We’ve also helped clients post-acquisition.
With deep experience in a range of pathways for pharmaceuticals and medical devices, our consultants provide regulatory support for both new product development and lifecycle management.
For demonstrating value to healthcare providers and operationalizing KOL insights, we provide technology implementation and change management project teams as well as therapeutic area SMEs (including medical science liaisons and Phase 4 medical experts).
With project leaders (as high-level as IMO directors) and subject matter experts (including TSA experts, technology integrators, and specific workstream leads) we provide cross-functional divestiture and integration support.
Our subject matter experts (such as product-specific solution architects) and project teams bring a holistic, disciplined approach to global software implementations (including ERP, PLM, CRO, PPM, and beyond) to ensure efficient, effective digital transformation.
From manufacturing tech transfers to supply chain harmonization and beyond, we help life sciences leaders drive efficiencies, tackle challenges, and realize opportunities.