INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.

  • Gene therapies hold immense potential to provide long-lasting treatments for a wide range of diseases. At Cytiva, we offer GMP-compliant, end-to-end manufacturing solutions designed to support the development and commercialization of advanced medicines across multiple modalities – including AAV, adenovirus (AV), lentivirus (LV), plasmid DNA (pDNA) and exosomes. Our dependable suite of technologies and expertise ensures scalability, quality, and regulatory confidence at every stage of your journey.

  • Delivering on the promise of cell and gene therapy through Germfree products and services.

    Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

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

  • 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.