Ultra High-Volume Scanners

PRODUCTS

  • Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.

  • Mycenax’s state-of-the-art biomanufacturing site is PIC/S GMP certified. Our highly qualified and well-trained team routinely manufactures high-quality biopharmaceutical products by mammalian cell culture and microbial fermentation processes. We continuously invest in our technologies and infrastructure to ensure that we constantly meet your evolving needs of today and tomorrow.

  • There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

  • Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.

  • Manage inspection-ready clinical trial documents with confidence for faster study execution with TrialKit’s electronic trial master file system.

WHITE PAPERS AND CASE STUDIES

NEWS