Business Process Outsourcing

PRODUCTS

  • Create rich digital work instructions for better test method execution.

  • Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.

  • Companies vying to be the first to market with breakthrough treatments have a great deal riding on the success of their efforts. Incorporating innovative processes, ethical considerations, assuring the safety and efficacy of the product, and managing the commodity's environmental control are formidable challenges that often lack standardized quality control procedures. Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. The fragility of regenerative medicine therapies and the need to manage risk means a fourth link in the chain will soon be a regulatory requirement.

  • Subcutaneous

    Low - Medium Viscosities
    < 100 cP
    1 - 10 ml

    High - Ultra-High Viscosities
    >100 - 10,000 cP
    0.5 - 3 ml

    ArQ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in  less than 5 seconds. The ArQ-Bios  platform  also can deliver  greater volumes than 1 ml subject to matching  the formulation characteristics with acceptable patient tolerability.

  • Using Document Change Control Software in Regulated Environments

    Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.

    In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.

WHITE PAPERS AND CASE STUDIES

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