Our specialized units cover diverse therapeutic areas such as endocrinology, metabolic disorders, cardiology, gastroenterology, women’s health, dermatology, hematology, and nephrology.
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.
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.