Sharepoint Solutions

PRODUCTS

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    Regulatory Sciences

    We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

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    Electronic Batch Records (EBR) Software For Drug Manufacturing

    Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.

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    Navigate The Early Phases Of Product Development With Ease

    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.

  • AAV Production
    Power Your Gene Therapy Pipeline With A Proven AAV CDMO Partner

    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.

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    Streamline Defect And Nonconformance Management

    Track and manage defects and non-conformances – such as SOP deviations or missing data – from identification to resolution.

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