Representative engagements and outcomes
Buy-side technical diligence to acquire a biobank for a healthcare company
Scope
Conduct full diligence including clinical validity, biobank operations, regulatory status, revenue pathway.
Outcome
Red-flag report and risk heatmap used to adjust offer; integration roadmap covering lab scale, QA/QC, and payer sequencing.
Establishment of a new pathology laboratory
Scope
Develop a centralised pathology laboratory for a clinical testing company based in San Francisco and Nigeria. Develop a comprehensive test menu and a CAP compliant infrastructure including genomics, microbiology and. clinical chemistry
Outcome
Developed a full scale CAP/CLIA readiness pathway. Developed lab SOPs and policies, hired an on-site compliance team, training and competency on CAP and quality management for on sitte lab staff, new test development in NIPT, somatic oncology.
CLIA/CAP readiness and validation plan for a scaling infectious disease and genomics lab
Scope
Product development for an adult onset cardiology genetic test, Development of SOPs, validation templates, vendor risk assessment, throughput & cost modeling.
Outcome
Inspection readiness; achieved target throughput with maintained quality KPIs.
