Nuventra’s nonclinical goal is to efficiently move our clients' compound into the clinic. We apply the smartest tools and strategies for attaining a successful IND and entering the clinic with a strong rationale for the first-in-human dose.
There is much more to early phase development than simply checking off required studies. We work with clients to create plans that ensure each early phase study fits into your overall drug development program. Before starting any clinical study, we ask: How do these studies fit into the overall drug development strategy? How can clinical pharmacology data support late phase, efficacy and pivotal study success? What other data will be required to support the submission?
Nuventra utilizes innovative modeling and simulation techniques to ensure that your program is ready for the approval process. Our Pharmacometricians ensure justification of dose for the marketplace, and author reports to detail their findings. We can use modeling and simulation to avoid certain late phase studies, scale to pediatrics, simulate entire studies, and more.
Nuventra has considerable experience with regulatory agencies around the globe. We work with our clients and the regulatory agencies to ensure that all documents are robust, insightful, scientifically focused and practical. You have invested significant resources to reach this point, contact the experts at Nuventra to ensure your submissions and/or strategic responses are well received by the agencies.