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.
Specialized cross-functional expertise across stage-gated product development, including Pharmaceuticals, Biologics, Combination Devices, and Medical Devices. We support global R&D projects from Discovery through Lifecycle Management.
Dedicated professionals to ensure Quality and Supplier systems process remediation: warning letter and consent decree prevention and remediation. Document control across design history files, device master records, drug master files, and labeling. CAPA and Adverse Events strategy and management.
Subject Matter Experts & Strategists specializing in specific approval pathway consulting for global submissions and approvals for drugs (IND, A/NDA, BLA, CBE, DMF Amendment, EMA) and devices (IDE, 510k, PMA, CE Marking Design).
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Simplify the complexities of navigating conflicting priorities, lack of visibility, talent scarcity and outdated technology.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.