Our Services

Jupiter Global Bio-Research specializes in BCS Bio-waiver studies, providing streamlined pathways for regulatory approval of solid oral dosage forms.

Our focused services include:

BCS Bio-waiver Studies: Conducting thorough analyses to support biowaiver applications based on the Biopharmaceutics Classification System (BCS).

• We facilitate BE waivers based on BCS classification, specifically for BCS Class I and BCS Class III drugs, accelerating product development and reducing regulatory burdens.
• We offer comprehensive BCS Bio-waiver Caco-2 packages, providing crucial in vitro data to support biowaiver applications.
• Our studies are tailored for solid oral dosage forms, ensuring accurate and relevant data for regulatory submissions.

Technical Expertise & Regulatory Compliance:

• We possess extensive knowledge of BCS principles and USFDA guidelines for biowaiver applications.
• Our expertise covers a range of USFDA Product-Specific Guidances (PSGs), including but not limited to: Capacitabine, Imatinib, Cyclophosphamide, Ramelteon, Varenicline, Vigabatrin, Azacitidine, Temozolamide, Docusate sodium, and Buspirone.
• We adhere to stringent quality standards and regulatory guidelines, ensuring the integrity and reliability of our study results.

By partnering with Jupiter Global for your BCS Bio-waiver studies, you gain access to our specialized expertise, efficient processes, and commitment to regulatory compliance. We deliver precise and comprehensive data, supporting your biowaiver applications and accelerating your product's time to market.