Who is NovaReg?
NovaReg is a specialist consulting practice supporting medical device and diagnostics companies through regulatory approval, product development, and quality system implementation.
Founded in Australia by Neralie Coulston, a senior regulatory strategist with over 20 years' experience, NovaReg delivers practical, senior-level support grounded in global regulatory frameworks including FDA, IVDR, ISO 13485, and MDSAP.
Whether you're early in development or preparing for market entry, we help bring your product to life - compliantly and efficiently.
NovaReg provides strategic and hands-on support across:
Regulatory submissions (FDA 510(k), TGA, IVDR, CLIA)
Quality system development and compliance (ISO 13485, MDSAP)
Product development and evidence planning (design control, risk management)
Regulatory submissions (FDA 510(k), TGA, IVDR, CLIA)
We work with start-ups, scale-ups, and established companies to design tailored, scalable solutions that accelerate progress and reduce compliance risk.
Meet the founder
With more than two decades of global experience, Neralie brings extensive regulatory, clinical, and quality expertise to each engagement. She has built regulatory and quality systems from the ground up ensuring compliant product design and development.
She’s worked across every stage of the product lifecycle, guiding innovations from concept through to clearance and commercialization. Her approach is collaborative, pragmatic, and grounded in the belief that effective regulatory strategy should inform and enable innovation rather than hinder it.
“NovaReg was founded to give companies the confidence to move forward. Whether you're new to regulatory concepts or just need some additional support, I’m here to help you navigate the path with clarity and confidence.”
Contact us
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