Product Development & Regulatory Consulting
Offering decades of strategic development experience, global compliance, and therapeutic experience to ensure your promising therapy isn’t delayed by risk or limited resources.
Achieving commercial success
Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success.
Product development checklist
A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success, especially for small biotech and specialty pharma companies working with limited time and resources.
Taking your product to the next level
Our consultants work with you to design and implement comprehensive plans to enable successful product development from early discovery through IND and post-approval lifecycle management, supporting the regulatory pathway and tactical implementation.
Product Development & Regulatory Consulting Experts
Shari Medendorp, MPH
Kristi Miller, Ph.D.
Nach Davé, RPh, M.S.
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.