Experts in Drug Development Programs
We add value to our clients’ drug development programs.
We provide expert advice on regulatory and commercialisation pathways, and facilitate regulatory processes.
Our Solutions
We have a strong track record of successful submissions, registrations, and developing pharmaceutical drugs globally. Our team has over 50 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.
Regulatory Affairs
Product Development
Vendor / Program Management
Medical Writing
Gene Therapy Applications / IBC
Institute Biosafety Committee (IBC) Services
We established one of Brisbane’s only non-university-based Institutional Biosafety Committee (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.
The GRS and the GRS IBC can provide classification advice, formally review licence applications, and approval before they are sent to the OGTR and provide ongoing support during the OGTR evaluation. The IBC also reviews and approves NLRDs for organisations that require IBC access and considers exemptions locally.
About Us
Graythan Regulatory Services (GRS) was established in 2017 to offer consulting services to support the biopharmaceutical industry.
We have a strong track record of successful submissions, registrations, and developing pharmaceutical drugs globally. We have a high client retention rate with most of our projects being returned clients. Our success is due to our wealth of capabilities and industry knowledge combined with a policy of team collaboration, engagement, and review. This ensures the highest level of quality assurance is produced for your project.
GRS will help you get to
Market
Meet The Team
William Browning-Zonneveld
Regulatory Affairs Manager
Barbara Kienast
Head of Clinical Operations and Regulatory Affairs
Mark Reid
Founder and Managing Director
We build GRS around our people to maximise individual value and focus on hiring the best people possible. Our team has over 50 years of collective experience in the pharmaceutical industry.
Our team is all personally invested in the development of innovations for healthcare. Our clients always have a personal contact person within Graythan that they can reach directly to ensure their needs are met promptly and accurately.
Choose Graythan to ensure the success of your drug development program
At Graythan, we strive to add value to our client’s drug development programs through expert advice on regulatory and commercialisation pathways and by facilitation of regulatory processes.
Talk to us today about how we can make a difference with your drug development program, and make it a success.
Extensive Knowledge
Our many talented people have up-to-date in-depth knowledge of the life sciences industry
Our Journey
We work closely with you to guarantee our services are tailored to your company’s specific needs
Proven Results
We have a strong track record of success, coupled with high client retention rates and quality assurance
Personalised Support
Each client has their own GRS Consultant who ensures your needs are met to ensure product success