Compliance

PRODUCTS

  • Delve into the details of this full-service global product development and strategic regulatory group that has a proven track record of successful FDA meetings and approvals.

  • Qorvo's QPA2811 is a high-performance, packaged X-band power amplifier designed for demanding applications such as military radar systems.

  • Single-Use System

    The UFMini is a single-use centrifuge designed for primary clarification of mammalian cell cultures (i.e., CHO cells), and harvesting (washing & concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications. This user-friendly system is the scaled-down version of our successful UniFuge® single-use centrifuge. The UFMini is intended for use in cleanrooms, in laminar flow hoods, and on benchtops.

    • Bowl capacity: 300mL
    • Flow rate from 29-1,000 mL/min
    • Small footprint: Centrifuge Enclosure 69 cm x 56 cm x 38 cm (27” x 22” x 15”)
    • Easy to handle: Total skid weight of ~40 kg (90 lbs)
    • Gamma-irradiated single-use modules
    • Processes scalable to UniFuge® Pilot and U2k®
  • Help your patients make informed decisions without burying them in paper

    With electronic informed consent (eConsent) software, your patients can access consent forms using any device they choose. And because it’s part of TrialKit’s unified platform, both your patients and your study team get a seamless experience.

  • Ensuring you have equipment that accurately and rapidly assembles syringes and cartridges is crucial to the success of your pharmaceutical manufacturing workflow. The Hull i-Dositecno SY pharmaceutical labeling machine harnesses dual-function robotics for plunger insertion and labeling to ensure the safety and sterility of your product.

    • Versatile – ideal for syringes or cartridges in sterile, clean, ready-to-fill (SCF) tubs
    • Cleanroom ready
    • Fully compliant – 21 CFR Part 11 software and IQ/OQ validation packages available

WHITE PAPERS AND CASE STUDIES

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