What We Do
Research and Development
Research and development have always been necessary to making improvements and growing businesses – especially in the healthcare sector. In 1984, Hatch-Waxman Amendments created a much-needed and streamlined pathway for drug development. This approach is known as 505 b(2). It eliminates the unnecessary duplication of research.
Research, at its core, is used for the approval of clinically significant improvements that are made for a drug with prior approval. By allowing for the use of data not developed by the NDA applicant, advancements can be made on a faster track. This can be lifesaving in many cases. The faster route to approval, when compared to traditional development pathways, creates new therapies, with the beneficiary of this new technology being the patient. By simplifying the process of drug development, discoveries can be made in a more efficient and effective manner, changing the course of medicine forever.
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Expert Development Plans
One of our major drug projects is focused on Multiple Sclerosis. We are working on obtaining an Orphan Drug designation with the FDA. Once achieved, we expect that it will help defer and lower the risks, as well as provide certain incentives, including, but not limited to: tax credits, grant funding, assistance for clinical research, and extended marketing exclusivity.
The drug is armed with initial clinical data which provides the foundational data set to present our development plan to regulatory authorities. This helps tremendously and reduces the complexity that was previously needed to perform the same operation.
Globe Star Therapeutics© utilizes these techniques in order to ensure maximum success and progress in taking medicine and whole health to the next level, while using our own research and development team to make new discoveries. Our team has significant expertise in the field of medical research and development. GlobeStar’s goal is always to pave a path to wellness for those afflicted with life-altering disease while continuing to seek a cure. For more information on GlobeStar Therapeutics please email us directly at email@example.com.