§ 03 / About Compliance simplified.
A consulting firm built around regulatory clarity, technical depth, and the practical mechanics of getting life-sciences companies inspection-ready.
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.
Our work spans quality management, regulatory submissions, cGxP operations, and the data infrastructure those domains increasingly run on — from gap analysis through inspections, validations, and the quiet maintenance that keeps systems audit-ready year after year.
Four principles that shape every engagement.
We assess your needs, map out risk-based solutions, and deliver audit-ready systems that scale with you.
- § 01
Regulatory clarity
We translate frameworks — FDA, EMA, ISO, ICH — into specific, defensible decisions for your product and stage. No hand-waving, no checklist theater.
- § 02
Technical depth
Quality, validation, and IT done by practitioners who've built, audited, and remediated the systems they consult on. We don't write what we haven't run.
- § 03
Risk-based delivery
We focus where risk actually concentrates. The result is inspection-ready outcomes without the bureaucracy that slows your teams down.
- § 04
Data-native compliance
Modern life-sciences orgs run on data. We design quality and regulatory systems around it — not around it.
Built by practitioners.
Two founders, two complementary disciplines — regulatory depth and technical depth — both with hands-on experience inside the systems we work on.
- § 01 Co-Founder & CEO
Moj Eram
Quality and regulatory expert in life sciences. Builds and remediates quality management systems for pharma, biotech, and medtech organizations — across pre-clinical through commercial stages. Background spans ISO 13485, ISO 9001, IEC 62304, 21 CFR 820, 21 CFR 210/211, and the EU MDR, with deep operational experience on the realities of inspection-ready compliance.
LinkedIn → - § 02 Co-Founder
Sean Cochrane
Software developer and technologist focused on regulated industries. Designs the systems where compliance meets modern data infrastructure — validated cloud architecture, computer system validation, governance, and the security controls that regulated customers expect. Bridges the gap between quality processes and the engineering teams that need to ship.
LinkedIn →
Want to talk through a project, evaluate a system, or just compare notes on a regulatory framework?
Get in touch →