Consulting Services

Vista Biologic Solutions Inc offers the following consulting services:

  • Early-Stage Biologics Development and Strategic Oversight – for vaccine and therapeutic products including subunit proteins, live viral vectors for vaccine and genet therapy, mRNA-LNP, monoclonal antibodies, and oncolytic viruses. Review of process and analytical development plans for risks, gaps, and inefficiencies.

  • CMC Regulatory Support – CMC DS and DP section preparation for Module 3 regulatory submissions, strategy documents, risk assessments, QBD approaches, comparability reports, contributions to IB and briefing packages.

  • Technology Transfer and Outsourcing – process and analytical transfer to CDMOs and CTLs, process validation support, and corresponding analytical test development and QC.

  • Due Diligence – technical analyses of CMC information for gap and risk identification.

  • Technical Writing – CMC documents, technical reports, SOPs, and publications.

  • Interim Leadership – for reorganization or sudden key leader loss to keep team functioning and alleviate burden on existing resources.