Blog
Keep up to date with the latest news from Instem.
Mutagenicity Assessment Under ICH M7: Scientific Principles Supporting Pharmaceutical Impurity Risk Assessment
Mutagenicity assessment is the critical first step in pharmaceutical impurity risk evaluation, and this blog explores the scientific principles underpinning robust ICH M7 assessments, from complementary QSAR methodologies and Ames study data to applicability domain...
Strengthening CMC Readiness with In Silico Insight
CMC readiness begins long before IND submission. Explore how early data-driven decision-making, predictive toxicology, and connected workflows can reduce risk, improve data quality, and simplify regulatory preparation throughout the drug development journey.
Webinar Recap: When SEND Quality Matters Most
Our recent webinar, “When SEND Quality Matters Most”, explored the recent FDA communications regarding data quality, why regulatory expectations are shifting, where common issues arise, and how organizations can strengthen confidence before filing SEND datasets...
The Changing Language of Clinical Trial Transparency
This blog examines how clinical trial transparency regulations are evolving and what organizations can do to keep up with expectations.
Webinar Recap: Closing Compliance Gaps with Compliance Builder
Comprehensive electronic recordkeeping is a cornerstone of all laboratory functions in regulated industries, but establishing and maintaining 21 CFR Part 11 compliance is challenging when processes are fragmented across multiple instruments and systems.
Advancing Risk-Based E&L Safety Assessment: The Role of ICH Q3E and Leadscope
As ICH Q3E advances a risk-based paradigm for E&L safety, the question is shifting from whether to assess risk toward how to do it consistently across a vast and diverse chemical space. Leadscope enables structure...
Enhanced Physiological Data Analysis with Advanced Sleep and Signal Processing Capabilities with NOTOCORD‑hem 5.3
Version 5.3 introduces new modules for automated and validated sleep analysis alongside improved signal processing and reporting, supporting robust and compliant physiological research.
Accelerating Non-GLP Drug Discovery with BioRails
From preparation to analysis and reporting, BioRails actively supports the entire experimental workflow.
Why QC Laboratories Can’t Afford Blind Spots in Their File Systems
FDA Form 483 observations related to data integrity remain a persistent issue for the industry, and the consequences for a lab are significant.
