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    Pharmaceutical Change Control Software

    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.

  • Pellicon Feature
    Achieve Linear Scalability With Capsules For Gene Therapy And Vaccines

    MilliporeSigma’s Pellicon® Capsules are ideal for single-use ultrafiltration and diafiltration of viral gene therapy and vaccine products.

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    Integrated Trial Services

    We work as a single provider to empower patient and site participation in clinical trials. Our Integrated Trial Services team is dedicated to creating partnerships with our Sponsor and CRO clients, building strategic and unique combinations of solutions to accelerate trial timelines.

  • How SimpleStep ELISA Works
    Sandwich ELISA Assays For Unparalleled Simplicity And Effectiveness

    SimpleStep ELISA® kits are sandwich ELISA assays that we have developed to be as simple and effective as possible. Unlike traditional sandwich ELISAs, which take more than three hours to run, SimpleStep ELISA kits generate data in just 90 minutes without compromising performance, using only one wash step and recombinant antibodies for exceptional specificity.

  • GettyImages-849207658 Drug toxicity concept
    NDA Submissions 505(b)(1) Or 505(b)(2)

    There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

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