Intelligent guidance to catalyze development and chart a strategic path to approval
From preclinical proof-of-concept candidates to approved products primed for post-marketing label extension, our Product Development experts will plan and coordinate each clinical, non-clinical, CMC/Quality, and regulatory activity for your product. We balance risk against accelerated timelines by optimizing regulatory interactions and strategically running the right studies at the right time. Our goal is to create a program strategy that will get your products to patients faster while preventing costly development missteps.
We have a dedicated team of cross-functional experts who serve as a cost-effective extension of your team and can provide targeted consulting engagements in any discipline, including regulatory, nonclinical, CMC, clinical pharmacology, clinical, data management, and biostatistics, as well as integrated, multidisciplinary product planning and support.
Our cross-functional collaborative approach allows us to identify challenges earlier, de-risk your development strategy, and eliminate the missteps and delays often caused by silos and handoffs – ultimately ensuring a consistent program that runs smarter and more efficiently.
Our end-to-end development guidance and support includes:
- Creation and implementation of an integrated program strategy and operational development plans, including gap analyses and integrated product development planning
- Development of the Target Product Profile, which will set nonclinical, clinical, CMC/Quality, regulatory, and commercial goals to achieve key milestones
- Product management and operational execution through full life cycle
- Coordination and execution of concurrent activities, including coordination of all nonclinical, CMC, phase I-IV clinical studies, and regulatory activities, to accelerate development timelines, maximize efficiency, and reduce cost
- Design, implementation, and conduct of clinical studies (Phase I-IV)
- Potential Problem Analysis and Proactive risk management/mitigation
Our extensive Project Management expertise, excellent communication and collaboration skills, and access to the latest technologies will keep your program on track.
The recent FDA approval of our innovative new therapy, AZSTARYS, is a transformational event for patients with ADHD and for KemPharm. Rho’s expertise played a role in the development program’s NDA success and their team was accountable and delivered without exception.
Andrew Barrett, CSO, KemPharm
David Shoemaker, Ph.D.
Senior Vice President, Research & Development
Jack Modell, M.D.
Chief Medical Officer
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Vice President, Clinical Operations
Vice President, Regulatory Strategy & Biometrics
Brenda Faiola, Ph.D., DABT
Director, Nonclinical Development
7 Essentials for Successful Drug Development
Far too often drug development programs fail, even when a drug or device had a favorable effect on disease outcome. Read this whitepaper to learn more about the essentials for successful drug development.