Regulatory Compliance Solutions

  1. 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.

  2. Integration That Powers Real-Time Automation Across Your Enterprise 8/8/2025

    Unlock seamless integration that delivers real-time automation, compliance-ready data, and no-code configuration to streamline workflows, unify systems, and scale without disruption.

  3. Regulatory Information Management Software For Manufacturing 8/21/2025

    RImanager centralizes regulatory and product data, integrates with production, and streamlines planning, tracking, and approvals to bring new drugs to market faster and reliably.

  4. 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.

  5. Composable MES For Pharma 6/30/2025

    The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).

  6. 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.

  7. Dynamic Vapor Sorption Analyzer 4/17/2023

    Discover a system for advanced engineering and attention to detail that provides enhancements in every aspect of DVS technology as well as a new level of user experience.

  8. Biosafety Testing 6/2/2025

    Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

  9. Pharmaceutical Operational Readiness Programs 10/24/2024

    Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.

  10. Global Experts In Nanotechnology And Drug Particle Engineering 3/9/2023

    Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."