.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