innovations during the drug
discovery phase.
We take a personalized and integrated approach to help our clients position their pipelines and companies for success offering a full range of development and commercialization services.
We are Halloran, a life science consulting firm, partnering to enrich your product development and business growth. We propel your organization further; positively impacting the health and wellbeing of patients around the world.
Building a collaborative relationship with the U.S. Food and Drug Administration (FDA) is an essential component of a robust product development strategy for sponsors intending to bring novel drugs, biologics, and/or devices to market. Fortunately, the FDA offers various opportunities for interaction and guidance throughout the development lifecycle. FDA meetings provide an opportunity for sponsors to educate the agency about their product(s) and the corresponding development strategies.
In turn, these meetings allow sponsors to seek input regarding available data, discuss evolving regulatory requirements, and identify potential gaps in the overall product plan. These interactions are often an invaluable tool for de-risking product development, particularly for sponsors advancing highly complex product modalities and/or pursuing novel therapeutic targets.
The purpose is to discuss and de-risk the study design for the next clinical trial and to ensure the CMC and nonclinical aspects of the program are in line with the FDA’s expectations for the next phase of development.
We are passionate about life sciences and dedicated to being your trusted partner. By collaborating with us, you'll benefit from our extensive industry expertise and innovative strategies, guiding your company through the intricate clinical, regulatory, and quality landscape. With our proven track record in overcoming complex ecosystem challenges and expediting development timelines, you can concentrate on groundbreaking science while we take care of the rest. Together, we will maximize your company's potential, driving both clinical and commercial success.