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.

Learn more about our Regulatory Strategy services and Clinical Development services.