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About

Systems Architecture Emphasis

Establishing Novo Compliance’s proprietary Regulatory Compliance ARC® as a dynamic framework built on health authority scaffolding, enabling scalable development, compliant delivery, and lifecycle sustainability across global life science ecosystems.

Global Integration Emphasis:

Deploying Novo Compliance’s Regulatory Compliance ARC®, rooted in the harmonized technical frameworks of USFDA, EMA, WHO, and ICH to guide the strategic evolution and operational resilience of life science organizations from innovation through post-market stewardship.

Our Vision

Vision Statement

Novo Compliance envisions a globally harmonized life sciences ecosystem where regulatory intelligence, quality systems, and innovation converge through adaptive, ontology-driven architectures. By institutionalizing our proprietary Regulatory Compliance ARC® and modular audit simulation frameworks, we empower organizations to anticipate change, accelerate market access, and sustain compliance across the full product lifecycle from early development to post-market stewardship.
Our Mission

Mission Statement

Mission- Novo Compliance advises, develops, and executes through our proprietary regulatory methodologies, our clients’ capabilities with empowering early-stage regulatory and quality strategies aligned with pre-clinical & preproduction product development advancing each clients innovation pipelines and market entry goals. Advising our clients journey from R&D, Phase I, through EOPI, II, into Phase III, regulatory submissions with Global Health Authorities complete responses, leading to market authorization, commercialization, and post-market lifecycle stewardship, we drive continuous innovation, cost efficiency, and sustained compliance across global jurisdictions.
Our Team

A Team With Proven Expertise

Here Our Expert Team Members

Peter Ackerman

Twenty-five years in strategic planning, leadership, and tactical execution in multiple life sciences domains supporting start-ups to Fortune 500 companies with Regulatory Compliance, Intelligence and Sciences from discovery through marketing authorizations.

Hamid Rassoulian

Thirty years’ experience in clinical sciences and bioengineering in various teaching hospitals leading cross-disciplinary medical device and IVD projects with specialties including neuroscience, laboratory medicine, research and development, and EU/US regulatory compliance for pharma and device manufacturers while simultaneously holding academic appointments.

Sr. SME IVDs

Twenty years’ experience in IVDs and specialized medical devices supporting global life science organizations

Sr. SME MDRs

Twenty -five years’ experience with Class II, III medical devices, regulatory compliance, clinical compliance and data management.

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