About Us

We're Building the Intelligence Layer for Regulatory Compliance.

Compliance today is document-heavy, fragmented, and difficult to defend. We believe it should be structured, traceable, and continuously validated.

Who We Are

We are a team of Founders, Life Sciences and MedTech Experts, Researchers, and Engineers with experience in AI, Scalable Secure Systems, and Regulated Environments. We are building Phablo to bring structure, traceability, and intelligence to modern regulatory workflows.

What Phablo Does

Phablo is a regulatory intelligence platform that:

Maps documents to regulatory frameworks

Identifies compliance gaps using AI

Enables expert-driven validation workflows

Improves traceability across evidence and decisions

Supporting EU MDR, EU IVDR, ISO 13485, and ISO 14971 today, with FDA and additional frameworks expanding over time.

Our Vision

A Smarter, More Connected Compliance Ecosystem

We envision a smarter, more connected compliance ecosystem where evidence is structured, readiness is clearer, and teams can move faster without increasing risk.

Compliance becomes continuous, not periodic

Evidence becomes structured, not scattered

Teams move faster with confidence

Our Founders

Marc Gerlach

Co-Founder & CEO

Operator across life sciences and international markets, with experience building and scaling ventures. Brings strong relationships across regulatory and commercial ecosystems, connecting innovation with real-world adoption.

Tharak Sreedharan

Co-Founder & Product & Technology

Seasoned founder and product-engineering leader across healthcare, fintech, and AI. Built products end-to-end from scratch and led global engineering teams at a high-growth, multi-billion dollar startup, scaling complex systems.

What We Believe In

Innovation

We use AI where it reduces complexity, not where it adds noise.

Simplicity

Compliance should be structured, understandable, and actionable.

Expert Control

AI supports decisions. Experts own them.

Security & Data Protection

Built for regulated environments with strong data protection, access controls, and secure handling of sensitive regulatory documents.

Audit Readiness

Designed to support traceability, documentation integrity, and audit-ready workflows across regulatory processes.

Scalable by Design

Built to support growing teams, large documentation sets, and evolving regulatory requirements.

Trusted by Industry Leaders

Backed by

Global early-stage venture capital firm backing ambitious founders

Trusted by

EU MedTech Teams

Supporting compliance workflows across EU MDR, IVDR, and ISO standards

Advisors

20+ Years MedTech Expertise

Senior leaders in regulatory affairs, quality systems, and life sciences

Built for teams navigating complex regulatory frameworks across global markets

Ready to see Phablo in action?

See how structured compliance intelligence can transform your regulatory workflows.