Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Straight From The Source: A Live Q&A With The Inventors Of KinetiSol™
Experts discuss a solvent-free fusion process for amorphous solid dispersions, highlighting formulation flexibility, scale-up, process control, and early strategies to reduce risk and support commercialization.
Conducting A CDMO Audit Day Efficiently: Practical Strategies
Efficient CDMO audits require strategic planning, clear communication, and real-time documentation to manage risks, avoid pitfalls, and strengthen compliance while protecting profitability and fostering collaborative partnerships.
From Day One Success To Everyday Improvement: The OR → OE Continuum
Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.
Optimizing Contamination Control: Strategy Planning And Execution
In a highly regulated environment, maintaining facility compliance is paramount. See how a robust contamination control strategy ensures compliance, product quality, and operational efficiency.

Analysis Of ADCs Using Hydrophobic Interaction Chromatography
6/18/2026

Accurate DAR analysis in HIC requires systems that withstand corrosive salt conditions. Bioinert flow paths and baseline correction tools improve reproducibility, enabling confident characterization of ADCs.
From Protocol To Pull: Why Stability Studies Slip - And How To Regain Control
3/6/2026

Stop chasing missed pull windows caused by disconnected spreadsheets. Centralized, automated systems ensure regulatory compliance and keep your critical stability studies on track today.
Real-Time Monitoring And Automated Sampling For Enhanced Efficiency
3/17/2025

Integrating real-time, in-line monitoring with automated sampling in bioprocessing enhances efficiency and precision. Discover how advanced spectroscopy provides non-destructive insights to optimize cell growth and productivity.
QMSR Is Done. Now What?
9/1/2026

Align with FDA QMSR requirements by integrating ISO 13485 standards, moving quality management upstream, and tracking process health metrics to ensure continuous regulatory compliance.
Gain Insights And Speed With Remote Monitoring Of Equipment
3/10/2026

Real-time equipment insights are reshaping how biopharma teams maintain uptime. See how data-driven oversight enables faster responses, smarter decisions, and more resilient operations.

Medical Device Solutions: Enabling Regulate, Device-Integrated Liquid Manufacturing

Streamline regulatory pathways and reduce risk with device-integrated liquid solutions, validated cleanroom filling, and custom packaging.
Quality, Compliance, And Regulatory Services For Life Sciences

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
Leading The Way In Rapid Quantitation Of Host Cell DNA

Accurate, high-sensitivity quantitation of residual host cell DNA becomes faster and more consistent with integrated qPCR, automated prep, and broad assay coverage—helping streamline workflows.
Batch Manufacturing Software For Pharma

Visualize Batch Production Like Never Before

TrackWise Experion® Batch combines compact Experion distributed control, batch automation, and advanced visualization technology to provide a solution optimized for pharmaceutical, specialty chemical, food and beverage, and similar applications.
Risk Tool Selector: Match The Framework To The Decision

Match each CMC question to the right risk framework. See which tools help identify risk, reveal its drivers, and prioritize action across development and lifecycle risk management.