Project and Program management leaders with deep industry expertise and top talent to accelerate delivery of key initiatives from strategy to execution.
Clinical study managers, portfolio managers, lead CRA's, audit readiness consultants, biomarker and technical operations leaders, and study clinicians. Support for all therapeutic areas, from Discovery through Phase IV across Pharmaceuticals, Biologics, and Device 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.
Physicians, scientists, and medical monitors to drive global affairs strategy & operations, safety, communications, post-launch trials, Therapeutic Area (TA) and Disease specific support. Pharmacovigilance and Medical Safety, compliance operations, product launch and support. Key Opinion Leader (KOL) Facilitation and Management.
Change Management experts to support transformation, mergers, acquisitions, divestitures, integrations, and spin offs across business and technology. Master Data, records, and document management. Transitional Service Agreements (TSAs) and process/SOP integration & alignment.
Global Software Implementations (ERP, PLM, CRO, PPM), data management, and process re-engineering. Build next generation enterprise digital platforms leveraging Agile, UX design, product strategy and full stack development to advance your innovation agenda.
Simplify the complexities of navigating conflicting priorities, lack of visibility, talent scarcity and outdated technology. Manage track and trace, serialization, and auditing/managing key suppliers. Manage Site separation and relocation, supplier quality, raw material and API development, validation of new lines from CMO partners as well as CMC management, and product expansion and launch.