Regulatory Submission Blog

In Silico & Data InsightsRegulatory SubmissionStudy Management

The Journey of a Molecule – Target Identification

Instem Team

With integrated, insight‑driven platforms that cut through data complexity and eliminate fragmented workflows, Instem empowers researchers to reduce risk, boost efficiency, and accelerate the journey from discovery to IND submission.

Regulatory ComplianceRegulatory SubmissionRegulatory SubmissionsSENDSensible SEND

An Easy Guide to Reviewing SEND v4.0

Marc Ellison

SEND Implementation Guide v4.0 is the biggest change I’ve seen to the standard in the 15 years I’ve been involved. Here’s what you need to know.

AgencyBiotechCorporateCRONon-ProfitPharmaceuticalPre-ClinicalQuality ControlRegulatory SubmissionResearchResources

White Paper: What is Quality Assurance?

Instem Team

This white paper explains the fundamentals of quality assurance and why strong QA systems are essential for maintaining data integrity, compliance, and operational excellence in modern laboratory environments.

AcademicBiotechCROIND ReviewPharmaceuticalRegulatoryRegulatory SubmissionRegulatory SubmissionsResourcesSENDSEND Advantage Services

White Paper: How SEND Supports Ethical Innovation with the VICT3R Consortium

Instem Team

This white paper explores how SEND-aligned data management is enabling the development of virtual control groups (VCGs), a transformative approach with the potential to significantly reduce animal use in preclinical drug safety studies.

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