INSIGHTS ON REGULATORY COMPLIANCE

• The Role Of CDMOs In Supporting Generic Drug Development

  Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.

• Analytical Strategies To Address Common Development Challenges

  Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

• What Do You Need To Do To Qualify A Single-Use Assembly?

  Learn about the implementation of single-use technologies, single-use user requirement specifications, and best practices for single-use qualification, including quality and regulatory documentation.

• Optimizing Cleaning And Disinfection As Part Of An Effective CCS

  Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

• Sample Preparation Automation For Immunosuppressant Drug Analysis

  10/10/2025

  Discover how automated sample prep for immunosuppressant drug analysis improves accuracy, reduces contamination, and streamlines LC-MS/MS workflows.

• Accelerated Tox Offerings: A Recipe For Streamlining IND Applications

  4/22/2025

  Accelerating the timeline to tox material can significantly enhance the drug development process, enabling faster IND submissions and providing crucial time savings for toxicology studies.

• The Critical Role Of Product Inspection Systems In Manufacturing

  4/21/2025

  Explore the vital role of product inspection systems in manufacturing as well as learn how checkweighers, metal detectors, and x-ray inspection ensure quality and safety across various industries.

• Outsourcing To ISO 17025 Accredited Suppliers

  1/28/2025

  Discover the advantages of outsourcing equipment calibration to ISO 17025 accredited suppliers, including cost efficiency and regulatory assurance, in our detailed analysis. Read more to transform your calibration processes.

• A Regulatory Perspective: How Government Funding Spurs Scientific Innovation

  3/25/2024

  Review the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy.