Regulatory Compliance Solutions

  1. An Altogether Different CDMO Ready To Meet Your Needs 7/29/2024

    We offer end-to-end development services for pharmaceutical and biotech companies and provide expertise in clinical manufacturing, scale-up, cell cultures, API synthesis, and more.

  2. 21 CFR Part 11 Compliance Checklist For A Universal Pump 5/7/2024

    This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.

  3. GxP Compliance Solutions For GMP/GLP Labs 3/31/2025

    Advanced microplate detection systems and software help ensure top data integrity for your processes. Discover solutions and support that can enhance precision and compliance in your research and assays.

  4. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).

  5. Compliance Program For EU Annex 1 Container Closure Requirements

    Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.

  6. Computerized System Validation Services 2/24/2025

    As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.

  7. Out Of Specification (OOS) Software For Life Sciences 8/23/2021

    The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

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

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  9. Setting New Standards In Active Air Monitoring 8/25/2025

    By combining proven performance, refined data handling and smart features, the MAS-100 Sirius® air sampler makes active air monitoring in high-grade cleanrooms more reliable and convenient than ever before.

  10. Quality, Compliance, And Regulatory Services For Life Sciences 12/21/2020

    The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.