WE DON'T JUST ADVISE — WE DELIVER.
RSP brings deep, current expertise across all aspects of medical product development.
At the therapeutic level, our focus includes rapidly changing areas such as oncology, rare diseases, cell and gene therapy, neurodegenerative diseases, biosimilars, anti-infectives and combination products.
RSP brings deep, current expertise across the science, regulation, and policy of medical product development. Areas of particular interest include regulatory policy, expedited development, optimizing engagement with regulatory authorities, and eliminating unnecessary testing and studies.
We bring experience in study design and clinical testing; novel evidence sources, such as real-world data and real-word evidence; proactive identification and resolution of potential premarket hurdles; and assistance with post approval marketing, surveillance, and safety challenges.
Working with companies at every stage — from pre-revenue biotech to large-cap pharma — plus investment firms, consultancies, and academic institutions, RSP offers insights into the countless landscapes involved with medical product development. These include:
The SCIENTIFIC Landscape
From study design and real-world evidence to novel data sources, we harness the science that drives your submission forward and gives reviewers the clarity they need to say yes.
THE LIFECYCLE LANDSCAPE
From first in human — ideally even before — to approval and beyond, we work with you to achieve the full potential of your asset for both patients and shareholders.
THE REGULATORY LANDSCAPE
FDA is changing at an unprecedented pace. We bring first-hand, current knowledge of agency priorities, personnel, and processes — so you're never caught off guard. We navigate; you advance.
The Organizational Landscape
Great science needs great teams. We build high-performing, collaborative organizations — coaching executives, restructuring leadership, and closing talent gaps that are holding your program back.
Therapy Areas of Focus
RSP brings deep, current expertise across the science, regulation, and policy of medical product development — in therapeutic areas as diverse as oncology, rare diseases, neurodegenerative disorders, biosimilars, cell and gene therapies, and combination products. We work with companies at every stage — from pre-revenue biotech to large-cap pharma — as well as investment firms, regulatory consultancies, and academic institutions.