INSIGHTS ON REGULATORY COMPLIANCE

• Harmonizing Regulatory Guidelines For Assay Validation

  Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

• Why Biopharma Breakthroughs Aren't Moving The Market

  Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

• Environmental Microbial Monitoring In Advancing Automation

  Watch how a single-use microbial impactor revolutionizes contamination control in robotic filling lines to enhance sterility, efficiency, and compliance in fully automated manufacturing environments.

• Are You Aligned With FDA's Computer Software Assurance Methodology?

  Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.

• Normalized Data In Microbial Continuous Monitoring

  7/24/2025

  Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

• Why The Latest Technology Helps Navigate Evolving Regulator Expectations

  11/27/2024

  By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.

• Implementing Rapid Microbial Identification In Biotherapy Manufacutring

  5/27/2025

  Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.

• Client Story: Efficiency Enabling CSV At Scale

  7/1/2025

  Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

• Why Compounding Pharma Manufacturers Should Evaluate BFS Systems

  12/5/2024

  Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.