Business Process Outsourcing

PRODUCTS

  • FSMA Compliance Enterprise Software
    FSMA Compliance Enterprise Software

    If meeting customer demands was not challenging enough, there are the additional needs for ensuring compliance with FDA 21 CFR Part 11 requirements, FSMA regulations, USDA and trade stipulations. Process manufacturers must have the ability to quickly track and trace materials and costs throughout the supply chain, both as a matter of best practice and to support regulatory compliance.

  • Performance Management Software For Life Sciences
    Performance Management Software For Life Sciences

    Your process is only as effective as the poorest performing equipment on the line. This constrains profitability, schedule compliance, uptime and safety.

  • TrialScope Transparency Management
    TrialScope Transparency Management

    CLINICAL TRANSPARENCY
    Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.

  • Medical Grade Silicone For Medical Device Components
    Medical Grade Silicone For Medical Device Components

    Flexan/FMI uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.

  • Regulatory Affairs
    Regulatory Affairs

    Our team of Regulatory Affairs experts plays a pivotal role in your project from start to finish. In addition to compliance with applicable laws and guidelines, they scrutinize the appropriate licensing and legal compliance of pharmaceutical and medical products, thereby ensuring the quality, safety and efficacy of products.

WHITE PAPERS AND CASE STUDIES

NEWS

  • New Laser Makes Silicon ‘Sing’

    Yale scientists have created a new type of silicon laser that uses sound waves to amplify light. A study about the discovery appears in the online edition of the journal Science.

  • Light From Ancient Quasars Helps Confirm Quantum Entanglement

    Last year, physicists at MIT, the University of Vienna, and elsewhere provided strong support for quantum entanglement, the seemingly far-out idea that two particles, no matter how distant from each other in space and time, can be inextricably linked, in a way that defies the rules of classical physics.

  • Researchers Move Closer To Completely Optical Artificial Neural Network

    Researchers have shown that it is possible to train artificial neural networks directly on an optical chip. The significant breakthrough demonstrates that an optical circuit can perform a critical function of an electronics-based artificial neural network and could lead to less expensive, faster and more energy efficient ways to perform complex tasks such as speech or image recognition.

  • Pharma Group MSD (Merck) Announces Plans For New Biotech Facility In Dublin Ireland

    Pharma group MSD has announced plans for a new biotech facility in Dublin in a move that is expected to create 350 jobs.

  • Stryker To Pay $190M For Surgical Device Maker Invuity

    Invuity, Inc. (NASDAQ: IVTY), a leading medical technology company focused on advanced surgical devices to enable better visualization, today announced it has entered into a definitive agreement with Stryker Corporation (NYSE:SYK), pursuant to which Stryker will acquire all of the outstanding shares of Invuity for $7.40 per share in cash, implying a total equity value of approximately $190 million.