Genisage is a specialized consulting firm helping life sciences companies navigate the complex intersection of regulatory compliance, quality systems, and modern data infrastructure. Our mission is to empower innovation through compliance—whether you’re launching a new therapeutic, scaling a quality system, or preparing data for AI-driven insights.

We work with pharmaceutical, biotech, medical device, and diagnostics companies to build inspection-ready systems, achieve regulatory approvals, and manage data in a way that is structured, traceable, and aligned with global regulatory expectations.

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Our Services Include:
Quality & Regulatory Consulting
	•	Quality Management System (QMS) development & implementation
	•	Medical Devices, Combination Products, Pharma
	•	ISO 13485, 21 CFR 820, 211, and Part 4 compliance
	•	Internal audits, CAPA, risk management, and audit readiness
	•	Regulatory strategy & submissions  
	•	Audits: Supplier, Internal, Surveillance, ISO readiness, MDSAP Readiness, EU MDR 


Data & Technology Consulting
	•	Software Lifecycle Development
	•	AI/ML validation & audit readiness
	•	Data readiness: curation, governance & labeling
	•	Regulatory compliant data infrastructure (SOC2, GDPR)
	•	GxP-aligned cloud architecture (AWS, Azure)
	•	Information and Cybersecurity 
	•	IT vendor qualification for regulated environments

Whether you’re preparing for inspection, validating software, or scaling AI solutions, Genisage delivers innovative, compliant solutions built for regulated success.

🌐 www.genisage.com

Genisage

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Genisage

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