Blog

Keep up to date with the latest news from Instem.

Compliance BuilderPre-ClinicalQuality System ManagementRegulatoryRegulatory Submission

Webinar Recap: Closing Compliance Gaps with Compliance Builder

Instem Team

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.

CRODiscoveryIn Silico & Data InsightsIn Silico InsiderLeadscopeLeadscope Model ApplierPharmaceuticalPre-ClinicalPredictive ToxicologyToxicology

Advancing Risk-Based E&L Safety Assessment: The Role of ICH Q3E and Leadscope

Jignyasa Bal

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...

AgencyArtificial Intelligence and Machine LearningClimbCompany NewsCROPharmaceuticalPre-ClinicalProvantisRegulatory ComplianceRegulatory SubmissionsSENDSEND Advantage ServicesStudy ManagementSubmit

Instem Interact 2026 – A Resounding Success

Instem Team

Turning Insight into Innovation in Preclinical R&D

Regulatory ComplianceRegulatory SubmissionRegulatory SubmissionsSENDSensible SEND

What the FDA Webcast Revealed About SEND (and Why It Matters)

Marc Ellison

“For the first time, the FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. Just a clear statement that quality matters, and that poor SEND has...

Stay up to Date

Get expert tips, industry news, and fresh content delivered to your inbox.