Records Management

PRODUCTS

  • With over 130 in-life gene therapy studies completed, Altasciences is a leading expert in gene therapy research, with integrated preclinical and bioanalytical capabilities.

  • Are you anticipating rapid growth, getting ready for an equity event, or coming off a legacy system? NetSuite ERP’s all-in-one cloud business management solution helps future-proof your organization, eliminate redundancies and data silos, and automate manual processes, so you’re always ready for your next business milestone.

  • 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.

  • Werum PAS-X Savvy accelerates bioprocessing with real-time data management, visualization, and analysis—enabling agile development, robust decision-making, cost reduction, and consistent quality across pharma and biotech production lifecycles.

  • Controlled by software designed to meet 21 CFR Part 11 regulatory standards, Prometheus Panta C facilitates data integrity through distinct user access groups, while Active Directory integration provides centralized user authentication. Features such as electronic signatures, electronic records, and comprehensive audit trails further strengthen regulatory alignment.

WHITE PAPERS AND CASE STUDIES

NEWS