Product Development
& Regulatory Consulting
Developing the right product — supported by the right evidence for the right market at the right time — is both an art and a science. Our broad therapeutic expertise and decades of product development and regulatory experience help you map out and execute a just-right strategy to streamline the path to approval.
Taking your product to the next level
Product development is a journey, complete with speed bumps and forks in the road. Having a comprehensive but flexible plan for maneuvering your way from R&D and compliance to IND/IDE and commercialization allows you to keep your bearings and make smarter, more informed decisions. Our consultants collaborate with you to design and implement product development and regulatory strategies that work hand in hand to de-risk your program and move your product from one milestone to the next.
Therapeutic Focus
There’s no substitute for experience. And we have a lot of it. See what we’ve been busy doing for the past five years.
Integrations
Creative strategic solutions to overcome complex challenges and accelerate development
Industry leaders with comprehensive submission experience position your product strategically
Products manufactured for nonclinical and clinical testing and beyond
Quality, efficiency, and reliability from start to finish
Commercial solutions maximize the potential of your program throughout development and commercialization
A customized approach drawing on medical expertise
Managing & delivering every study with your business priorities in mind
Critical testing for assessing the safety and pharmacokinetic characteristics of your product
Insights
Agility and knowledge at your fingertips
Product Development Checklist: Navigating the Four Critical Stages of the Drug Development Process
The First Step for Streamlined CMC Development: Optimize the Target Product Profile
Meet the Experts
Product Development & Regulatory Consulting
Olu Aloba, Ph.D.
Will Bainbridge
Willette Jones Whitmore, CCRP
William Salminen, Ph.D., DABT, PMP
resources
Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.
Ready to get started? So are we.
Drop us a line to learn more about how we can help.