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Empowering Regulatory Confidence Through SEND Excellence

At Eniivance Solutions, we simplify regulatory data compliance for the global life sciences community by delivering accurate, validated, and submission-ready SEND datasets that sponsors and CROs can trust.

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Our Vision

To demystify and streamline regulatory nonclinical data compliance worldwide using innovation, integrity, and trusted partnership

Our Mission

To empower pharmaceutical sponsors, CROs, and preclinical research teams with SEND-ready solutions that accelerate regulatory submission readiness and minimize compliance risk.

Why We Started

Eniivance was founded by SEND and regulatory data experts who saw a growing challenge in nonclinical regulatory submissions: inconsistent standards, manual processes, and resource limitations often lead to delays, rework, and regulatory findings. We built Eniivance to solve these challenges — offering a reliable, quality-driven SEND service grounded in regulatory awareness and technical precision

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Leadership & Expertise

Our founding leadership brings 15+ years of experience in SEND implementation, nonclinical workflows, and regulatory compliance — blending scientific rigor with technical excellence to deliver audit-ready datasets with confidence.

What We Do

From dataset structuring and SEND mapping to QC, validation, and documentation, we support sponsors and CROs in generating fully compliant SEND deliverables aligned with CDISC standards and regulatory expectations.

Who We Serve

We partner with:

  • Global and regional pharmaceutical sponsors preparing toxicology and safety study submissions

  • Contract Research Organizations (CROs) and preclinical laboratories requiring SEND expertise

  • R&D teams scaling SEND across multiple studies or converting legacy datasets

  • Organizations seeking consistent, validated SEND workflows for regulatory submission confidence

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Our Commitment

We are committed to:

  • Accuracy and traceability

  • Transparent, governed data workflows

  • Consistent SEND quality

  • Minimizing regulatory validation findings

Our approach blends automation, regulatory insight, and quality control to accelerate your path to submission with confidence.

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