Global Pharma Solutions (GPS): Experienced professionals accelerating medicine registrations globally.

GPS is a global regulatory and product development consulting firm with experts in both the US and Australia. We have over 22 years’ experience in developing and registering hundreds of products including small molecules, biologics and medical devices and 11 years’ experience with cell and gene therapies, particularly liaising with the FDA.

We guide biotech companies through complex development pathways, ensuring a clear route to market approval.

Through our partner CROs, we also offer support with clinical operations.

Why work with us

We are keen to connect at Bio Korea to discuss how we can support your clinical development, regulatory strategies and overall development objectives.

Each of our experts has more than 20 years' experience in developing and registering medicines and devices globally. We have supported several hundred development programs in many indications and have close to 100% approval success with global regulatory agencies.

In addition, with operations in both the US an Australia we are uniquely positioned to lend our global expertise to guide your program from preclinical, to clinical and final registration, using our valuable knowledge and wisdom, which has been proven to could save our clients significant amounts of time and money.

Having conducted your early clinical trials in Australia, our experts can help you open an IND in the US and potentially gain accelerated pathways and designations to expedite your program. This can also increase the value of your asset for a potential early exit.

There is no substitute for a knowledgeble team guiding you. Experience matters.....