505(b)(2) 505(b)(2) The 505(b)(2) NDA pathway offers a streamlined approach to drug approval, enabling the development of innovative products by leveraging existing data. This pathway allows for the submission of a new drug application that includes full reports of investigations of safety and effectiveness, with at least some of the information required for approval coming from studies not conducted by or for the applicant. At Viora, we specialize in guiding clients through the 505(b)(2) process, offering:  Regulatory Strategy Development: Our experts assist in designing regulatory strategies...

Orphan Drugs Orphan Drugs Our dedicated orphan drug services address the unique challenges of developing therapies for rare diseases. From strategic advice and regulatory support to tailored manufacturing solutions, we partner with you to navigate the complexities of orphan drug development, aiming to bring life-changing treatments to underserved patient populations

Hazardous Molecules Hazardous Molecules We specialize in the safe and compliant development of hazardous Molecules, employing advanced process safety measures and specialized facilities to handle potent compounds. Our experts utilize comprehensive calorimetric and analytical methods to identify and mitigate risks, ensuring the safety and efficacy of your products

Stability Services Stability Services Our analytical method validation services ensure that your methods meet rigorous regulatory standards, including ICH and FDA guidelines. We validate methods to confirm their accuracy, precision, and reliability, ensuring consistent quality throughout the product lifecycle