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