Intelligent guidance to catalyze developmentand chart a strategic path to approval

From preclinical proof-of-concept candidates to approved products primed for post-marketing label extension, our ProductDevelopment experts willplan and coordinate each clinical. non-clinical, CMC/Quality, and regulatory activity for yourproduct. We balance risk against accelerated timelines by optimizing regulatory interactions and strategically running the rightstudies at the right time. Our goal is to create a program strategy that wil get your products to patients faster while preventingcostly development missteps.
 

We have a dedicated team of cross-functional experts who serve as a cost-effective extension of your team and can providetargeted consulting engagements in any discipline, including regulatory nonclinical, CIC, clinical pharmacoloay, clinical, datomanagement, and biostatistics, as well as integrated, multidisciplinary product planning and support.
 

Our cross-functional collaborative approach alows us to identify challenges earlier, de-risk your development strategy, anoeliminate the missteps and delays often caused by silos and handofs - ultimately ensuring a consistent program that runssmarter and more efficiently.

Our end-to-end development guidance and supportincludes:

• Creation and implementation of an integrated program strategy and operational development plans,including gapanalyses and integrated product development planning

• Development of the Target Product Profile, which will set nonclinical, clinical, CMC/Quality, regulatory, and commercialqoals to achieve key milestones

• Product management and operational execution through full life cycle

• Coordination and execution of concurrent activities. including coordination of allnonclinical.CMC. phase -lV clinicastudies, and regulatory activities, to accelerate development timelines, maximize efficiency, and reduce cost

• Desian, implementation, and conduct of clinical studies (Phase l-IV)

• Potential Problem Analysis and Proactive risk management/mitiaation
 

Our extensive Project Management expertise, excellent communication and colaboration skills, and access to the latesttechnologies wil keep your procram on track.
 

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

The recent FDA approval of our innovative new therapy, AZSTARYS, is atransformational event for patients with ADHD and for KemPharm. Rho'sexpertise played a role in the development program's NDA success and theirteam was accountable and delivered without exception.

Andrew Barrett, CSO, KemPharm