Basic Info

Graythan Regulatory Services (GRS) was established in 2017 to offer consulting services to support the biopharmaceutical industry. Our team has over 75 years of collective experience in the pharmaceutical industry with a specialty in readying stalled or legacy products to swiftly enter the clinic or gain marketing approval.

GRS operates one of Australia’s first and privately-owned commercial IBC to provide classified advice, and formally review license applications on gene technology in Australia before submitting them for the Office of Gene Technology Regulator (OGTR) evaluation.

Our beginnings started when our founder saw the need for expert advice on regulatory and commercialisation pathways for emerging biotechnology. His wealth of experience in drug and vaccine development built the foundations for GRS to thrive.

Why work with us

With a proven track record of bringing prodcuts to the market spanning 34 countries, our multidisciplinary, multinational team brings hard-won practical expertise to every engagement. If you're looking for a regulatory partner who has navigated the complexities of global drug development firsthand — we'd love to hear from you. We also cover local sponsorship, Resident Austrlaia Director Support, R&D tax filing and more

Graythan Regulatory Services | Drug Development Programs

Brochure

Company focus

Services

Therapeutics
Contact Research Organisation (CRO)
Industry Service Provider
Research

Industries

Medical Devices
Pharmaceuticals

Projects or Case studies (2)

Delivery of a global project with 8,807,331 percent ROI

September 2016 - September 2025

Multinational drug approval and role out in 34 countreis.

Deliver of Phase 1 projects

October 1925 - January 1926

Delivered a Phase 1 study 9 month ahead of schedule

Contacts

Barbara Kienast Avatar

Barbara Kienast

Head of Clinical Operations and Regulatory Affairs

Mark Reid Avatar

Mark Reid