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Navigating the regulatory landscape

We Are Precision Healthcare Solutions

We are a boutique consulting firm specialising in designing and conducting small-scale clinical trials and obtaining regulatory approval of medical devices. Established in 2020, Precision Healthcare Solutions quickly took on the challenging COVID-19 landscape and the host of new medical products requiring regulatory approval. Our team is composed of experts with clinical, corporate and digital backgrounds.

Modern Work Space

Our Specialties

We offer a range of services in the clinical consultancy space

Business Meeting
Business Meeting
Brainstorming

Clinical Trials

An in-depth understanding of TGA and FDA requirements enables us to design each clinical trial with the entire approval process in scope. Our in-house clinical expertise also positions us to conduct end-to-end clinical trials.

Regulatory Approval

We have a proven track record of working with clients to meet TGA and FDA regulatory requirements for medical device approval.

Governance

With our extensive background in clinical and corporate governance, we work with clients to introduce new devices in both clinical and corporate settings by developing governance frameworks, standard operating procedures, and risk assessments.

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