From Study to Submission: Solutions for Complete Regulatory Confidence
For over 25 years, Instem has helped 700+ pharmaceutical, biotech, and CRO clients accelerate drug development while ensuring global compliance.
Not Just Compliance, but Co-Authorship
Unlike vendors who simply claim compliance, Instem’s team members are contributors to regulatory standards. We don’t just follow requirements; we help shape them through our FDA Research Collaboration Agreement and active CDISC participation.
Transparent Science, Not Black-Box Algorithms
Our in silico predictions show you exactly how conclusions are reached, with full access to the underlying data, structural alerts, and expert rules. The world’s largest curated toxicity database (600,000+ studies, 200,000+ chemicals) powers confident safety decisions you can defend to any regulator.
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700+
Clients Worldwide
Key SEND Standard Contributors
21 CFR Part 11
Compliant
CDISC
Active Member
Built by Scientists, Trusted by the World’s Leading Life Sciences Organizations
25+ Years of Regulatory Expertise
For decades, we’ve supported every major regulatory evolution: from paper submissions to electronic data standards. We didn’t just adapt to SEND; we helped develop it. When regulations change, our experts have you covered.
End-to-End Platform Integration
Stop wrestling with disconnected systems. Instem unifies study management, in silico predictions, data analysis, and regulatory submission—eliminating handoffs and data reconciliation headaches.
Proven Results
Our customers achieve 15-18% cost reduction and 50% faster reporting. Many have partnered with us for over 20 years, choosing to grow with Instem through preclinical expansion, mergers, and global operations.
One Partner for Your
Entire Preclinical-to-Clinical Journey
Provantis®
GLP study management and data capture, called the “gold standard globally” by toxicology professionals.
Leadscope Model Applier™
FDA-validated QSAR models for predictive toxicology. Reduce animal testing while meeting regulatory requirements.
SEND Advantage Services
Industry-leading SEND expertise. Submissions accepted by FDA, EMA, and PMDA without deficiencies.
Centrus™
Translational safety platform connecting preclinical findings to clinical outcomes for smarter decisions.
Wherever Your
Research Takes You
With offices across North America, EMEA, and APAC, Instem provides local support backed by global regulatory knowledge. Whether you’re navigating FDA, EMA, or PMDA requirements, our team understands the nuances that matter to your submissions.