Regulatory Compliance Solutions

  1. 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.

  2. Solutions For Modern Labs To Advance Science And Healthcare 10/1/2025

    Discover how collaboration and reliability drive meaningful impact across the healthcare and life sciences industries by empowering innovation from lab to clinic.

  3. Regulatory Services Offering 12/3/2023

    Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.

  4. A Cloud-Based Quality And Compliance Solution 9/8/2025

    Empower smarter decisions by combining trusted Salesforce integration and AI-enhanced quality management to drive efficiency, scalability, and continuous improvement across your organization.

  5. FDA 21 CFR Part 11-Compliant Software 2/28/2023

    Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

  6. A Scalable, Benchtop Mixing System For Sensitive Fluids 11/3/2025

    Examine a scalable, benchtop mixing system designed for sensitive fluids and GxP environments that supports automated control, traceability, and compliance from early development through production.

  7. A Novel Platform for DNA-Seq Library Preparation 10/24/2025

    Efficiently prepare high-quality DNA libraries from ultralow inputs with a fast, automatable workflow to eliminate adaptor dimers, reduce cleanup steps, and achieve broad GC coverage.

  8. Streamline Your Workflow With Impressive Speed And Flexibility 10/10/2025

    Accelerate compound management with precision pipetting, smart automation, and scalable throughput with an intuitive software that simplifies complex workflows while enhancing traceability and compliance.

  9. Annex 1-Compliant Real-Time Viable Particle Counter 12/15/2022

    What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

  10. Programming Simplicity And Operational Consistency At Your Fingertips 10/29/2025

    Streamline your lab automation with a customizable touchscreen, dynamic programming, and real-time monitoring to boost productivity, minimize errors, and integrate data across workflows.