Discover Our Regulatory Affairs Expertise

At Greenlight Clinical, our dedicated Regulatory Affairs team is here to provide exceptional global advice and services to the pharmaceutical, medical device, and healthcare industries. With our experienced regulatory professionals, we can guide you through the entire process of bringing your product to market by offering regulatory advice and strategy during drug development, clinical studies, and marketing applications.

Australia offers a fast and cost-effective environment for conducting clinical studies. Our efficient clinical study approval process allows for the timely generation of clinical data, ensuring support for US FDA IND. With Greenlight Clinical, you can rely on our regulatory and clinical support for both Australia and the USA, as we help you piece everything together.

Discover more about why you should choose Australia.

We proudly offer comprehensive regulatory services in both Australia and the USA for pharmaceuticals, biologicals, advanced medical therapies, medical devices, and in vitro diagnostics. Our experienced regulatory professionals can handle Australian or US-specific components of ACCESS and Project Orbis submissions, including promise pilot pathways.

At Greenlight Clinical, we are here to assist you in your investigation into Australian pathways with TGA registration assessments. We also offer product-specific assessments to ensure compliance with Australian requirements, covering the Office of Gene Technology Regulator (OGTR), TGA Clinical Trial Application (CTA) and Clinical Trial Notification (CTN), HREC, and importation requirements.

Additionally, we can assess if your product is eligible for early TGA registration submission through provisional registration assessments, even before completion of phase III studies.

We are able to offer a range of services including TGA marketing applications for pharmaceutical and biological products, provisional, priority, and orphan drug designations, as well as GMP submissions and maintenance for overseas manufacturers.

At GLC we can also provide advice on TGA fast-track approvals, priority and provisional applications for oncology clinical trials. We can also assist in preparing and submitting AU components for FDA Orbis designated products and offer fast-track registration assessments, cost and timeline assessments, and marketing/advertising compliance services.

Our team can review your websites and promotional materials to ensure compliance with TGA, Medicines Australia, Medical Technology, and ASMI requirements.

For Medical Devices and IVDs, we offer FDA 510k and de novo submissions, as well as TGA submissions and maintenance.

We strive to provide seamless regulatory support throughout the entire product lifecycle, from development to post-marketing. Our expertise in both Australian and US regulatory requirements allows us to offer comprehensive services for pharmaceuticals, medical devices, and more. Trust Greenlight Clinical for all your regulatory needs, and let us help bring your product to market successfully.