Regulatory Compliance Solutions

  1. X-Ray Inspection Solutions For The Pharmaceutical Industry 2/6/2025

    Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.

  2. IDBS PIMS And Regulatory Compliance 4/4/2025

    Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.

  3. Cleanrooms And Equipment For 503B Outsourcing Facilities 6/9/2023

    Germfree understands the unique challenges associated with 503B sterile drug compounding

    Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

  4. Biopharma Manufacturing Process Data Made Simple 9/6/2023

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  5. Quantitative Analysis With The SCIEX Triple Quad™ 5500+ System 6/19/2023

    The SCIEX Triple Quad™ 5500+ system is engineered to deliver best-in-class quantitative analysis.

    The best just got better. The SCIEX Triple Quad™ 5500+ system is equipped to conquer your laboratory’s most complex workflows and opportunities. With this LC-MS/MS system, you have the sensitivity and performance to meet analytical and regulatory demands for low-level trace detection with ease.

  6. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

  7. Cleanroom Capabilities And Expertise

    Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.

  8. Optima™ XPN Ultracentrifuge 6/16/2023

    1,500 mL max rotor capacity 100,000 max RPM 802,400 x g

    Security and tracking Remote monitoring and control eXPert simulation software.

  9. Sterile Cleaning Swabs 11/4/2022

    With more than thirty unique foam, polyester, and cotton swabs available, our CONSTIX® swabs product line offers a solution to almost any swab application challenge. Every CONSTIX swab has been designed with different lengths, head sizes, and materials to meet very specific customer needs.

  10. Highly Potent And Complex API Contract Manufacturing 4/23/2024

    Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.