Sharepoint Solutions

PRODUCTS

  • Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.

  • Ready to go deeper on cell characterization? Advance past typical cell and donor screening to create a comprehensive immune cell profile for each donor as well as an assessment of the metabolic and effector potential of their cells. See beyond surface markers too.

  • Kneat enables regulated companies to consolidate validation and quality management into a single end-to-end web-based software platform.

    CAI’s Kneat: Project-Ready allows your company to utilize a validated Kneat instance to execute your projects without start-up and on-going maintenance. Project-Ready does the heavy lifting for you with pre-designed processes and templates.

  • Early Phase Experts

    As a full-service contract research organization, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.

    With a broad range of experience delivering Phase 1 Healthy Volunteer, First in Human, First in Patient and Phase 2 trials, we know just how important it is for your asset to succeed in the early development lifecycle. Our experienced team will help you obtain high-quality data that will appeal to future investors, meet the requirements of international regulatory bodies such as the FDA, EMA, PMDA, and Health Canada, and prepare your product for larger Phase 3 and 4 studies, partnerships, licensing, and sale.

    Whatever your clinical trial needs, we can provide a flexible, bespoke solution that will not only meet your regulatory requirements but also position your product for commercial success.

  • With 30+ years of experience in viral vector development and manufacturing, we bring unmatched expertise as your trusted CDMO for AAV. From plasmids to fill/finish and advanced analytics, we provide true end-to-end support, accelerating your path to the clinic and beyond.

WHITE PAPERS AND CASE STUDIES

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