INSIGHTS ON REGULATORY COMPLIANCE

• Innovation And Efficiency - Visual Inspection In The 21st Century

  Digitizing your visual inspection processes is key to unlocking efficiency and ensuring compliance with global regulatory standards. Learn how to transition from paper-based systems to a digital database.

• The CMC Regulatory Landscape During Product Development, Manufacturing

  Through case studies and practical insights spanning complex drug substance and drug products like ADCs, learn more about navigating complexities with integrated regulatory services and strategic guidance.

• Top Safety Considerations In Biopharmaceutical Manufacturing

  Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

• Development Of Separation Methods For GLP-1 Synthetic Peptides

  Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

• GMP Compliance For Pharmaceuticals And Medical Devices

  3/14/2025

  Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.

• FDA's Advanced Manufacturing Technology Program

  5/6/2024

  Learn about a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability.

• Quality Roundtable: Raw Material Planning For Tech Transfer And Scaling Biologics

  1/22/2025

  Join this roundtable of biopharmaceutical professionals as they share their insights to help you navigate important quality and planning decisions for the progression of your biologic.

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

  3/19/2025

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

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  8/8/2025

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.