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REGULATORY AND BEYOND

Built for compliance, designed for progress

We embed regulatory excellence into every step. From FDA and TGA submissions to quality oversight and ISO-certified processes, we help you meet global standards today—and set you up for commercial success tomorrow.

Regulatory and Beyond

Trials need to be built with regulators in mind. This is why we ensure our trials are compliant with FDA CFR 21, TGA, EMA, and other regulatory bodies and standards. We also manage regulatory pathway assessments, submissions and more.

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What we can help with

  • Regulatory pathway assessment
  • Regulatory submissions support
  • Local Sponsor for Australia’s TGA CTN
  • ISO9001 certified QMS to ensure compliant, consistent document control, SOPs and training records
  • Compliance and CAPA systems
  • Independent Quality Assurance oversight
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What global teams say about us

Our reputation is built on responsiveness, reliability and compliance

CASE STUDY

Revolutionising sperm selection with safer, stress-free technology

A new electrophoretic system offered a faster, safer alternative to conventional sperm selection. In a multicentre pivotal trial, it outperformed Density Gradient Centrifugation, matched Swim-Up, and showed no adverse events—supporting CE Mark submission.

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CASE STUDY

Early feasibility to global pivotal trial for mitral valve innovation

An innovative repositionable mitral valve system underwent early feasibility trials in Australia before scaling to a global pivotal study. Results showed durable valve function, improved survival, and quality of life—culminating in CE Mark (2020) and FDA approval (2025).

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CASE STUDY

Validating a non-invasive pain relief device for pregnancy

Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.

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Guiding you through what you don’t know yet

We answer the questions you may not even know to ask, from readiness to cost, timelines to regulatory differences, so you can move forward with clarity.

What regulatory support do you provide?

We guide clients through TGA, FDA, and EMA pathways, prepare submissions, manage CTN notifications, New Zealand SCOTT approvals and act as Local Sponsor in Australia.

Can you help with post-market surveillance?

Absolutely. We assist with PMCF/PMCF studies, safety reporting, and ongoing clinical evaluation to maintain compliance after launch.

Do you provide support for reimbursement and market access?

Yes. Through our partner network we help define reimbursement strategies, code mapping, and health economics analysis to support commercial rollout.

What happens after a successful trial?

We prepare final clinical investigation reports and can assist with regulatory submissions, technical file compilation, and planning for pivotal or post-market phases.

Can you connect us with other partners we’ll need?

Yes. Our network includes experts in product development, manufacturing, regulatory strategy, pre-clinical testing, and commercialisation—ensuring continuity from lab to market.

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Trust Mobius to move 
your product strategy forward

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