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Innovative Pathways
for Generic Drug
Development

Delivering Safe, Effective, and Affordable Medications

Your Trusted
Partner in Generic
Development and
505(B)(2)
Applications

Our comprehensive services cover Bioavailability (BA) and Bioequivalence (BE) studies, crucial for the development of generic drugs and certain 505(b)(2) applications. BA studies measure the rate and extent of absorption of the active substance, ensuring it reaches the site of action effectively. BE studies compare the pharmacokinetic profiles of generic drugs to branded counterparts, ensuring no significant difference in safety or efficacy. This process is vital for obtaining regulatory approval and bringing safe, effective generics to market.

Advancing Medical Accessibility Through 505(B)(2) Pathways

The 505(b)(2) regulatory pathway offers an efficient route for bringing modified formulations, new combinations, or new indications of existing drugs to market. This pathway leverages existing safety and efficacy data, which can significantly reduce development time and cost. Our team is skilled in navigating the 505(b)(2) process, ensuring thorough documentation and compliance with FDA requirements to facilitate a smooth approval process.

Advancing Healthcare With Generic Drugs

Generic drugs play a vital role in modern healthcare by offering cost-effective alternatives to branded medications. The growing generic market presents opportunities and challenges, including the need to achieve first-to-market status. We understand the urgency and competitive pressures, managing studies with precision and within strict timelines and budgets. Our extensive experience across various therapeutic areas ensures successful bioequivalence studies that meet regulatory standards.

Your Premier Partner for Bringing Generics to Market

Since 2006, we have conducted over 1000 bioequivalence and related trials, providing high-quality data in compliance with good clinical practices (GCP). Our state-of-the-art clinical units and experienced staff ensure the highest standards of data integrity and patient safety. Whether working with healthy volunteers or specific patient populations, we are dedicated to delivering accurate and reliable study results.

Our extensive experience and expertise make us the ideal partner for your bioavailability, bioequivalence, and 505(b)(2) study needs. Collaborate with us to navigate the complexities of drug development and bring effective, affordable medications to market.

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