§ 00 / Genisage
Life Sciences Compliance,
data-enabled and audit-ready.
We help pharma, biotech, and medtech companies align quality and regulatory systems with modern data infrastructure — delivering scalable, audit-ready solutions built for innovation.
Grounded in regulatory clarity and technical depth.
We assess your needs, map out risk-based solutions, and deliver audit-ready systems that scale with you.
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Regulatory clarity
We translate frameworks (FDA, EMA, ISO, ICH) into specific, defensible decisions for your product and stage.
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Technical depth
Quality, validation, and IT done by people who've built and remediated the systems they consult on.
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Risk-based delivery
Audit-ready outcomes — without ceremony for its own sake. We focus where risk concentrates.
Four practices covering quality, regulatory, operations, and data.
Each engagement is shaped around the product, stage, and the realities of your next inspection.
All services →Quality Management
ISO-aligned quality management systems, audits, and design controls — built from gap analysis to ongoing internal review.
- Gap Analysis
- Quality Management Systems Build and Implementation
- Internal Audits / Supplier Audits / Mock Audits
Regulatory Compliance
Submissions, remediation, and EU/US regulatory strategy — built around the realities of inspections and post-market obligations.
- Regulatory Submissions
- FDA QSub
- FDA 483 / Warning Letters Remediations
cGxP
Validation, process optimization, and GLP testing across pre-clinical through early commercial — for peptides, biologics, devices, and combination products.
- Pre-Clinical / Clinical / Early Commercial
- Validation IQ / OQ / PQ
- Process Flow / Optimization
Data & IT
Computer system validation, cloud-native cGxP architecture, and the data governance that makes modern compliance possible.
- Software Lifecycle Development and Validation
- Information Management Systems
- Data Readiness — Curation, Labeling and Governance
Compliance simplified.
Genisage is a consulting firm focused on life sciences compliance and data readiness. We help pharma, biotech, and medtech organizations meet regulatory standards while building modern, audit-ready systems that support innovation and scale.
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