.02
Services
Strategic planning and tactical support for process development and manufacturing of:
Recombinant therapeutic protein products
Recombinant food products
Live Biotherapeutic (LBP) microbiome products
Evaluation of internal and external manufacturing processes
Evaluation and selection of external CMOs and CROs:
Authoring, issuing, and tracking of Request for Proposals (RFPs)
Evaluation and selection of CMOs and CROs based on issued proposals
CMO\CRO site selection audits
Oversight and management of interactions with selected CMOs\CROs
Leading biologics: manufacturing, process development, research, and project\program\portfolio management teams
Authoring CMC reports, and CMC sections of regulatory filing