Solutions
Tailored regulatory and FDA guidance to move early-stage medical products from bench to bedside
Medical product development requires navigating complex regulatory pathways and evolving FDA requirements. Scientific breakthroughs often begin with specialized knowledge and compelling innovation. However, limited regulatory and product development expertise is a risk.
As programs move from the laboratory toward clinical development, additional expertise is needed to translate promising science into a development strategy that meets regulatory expectations and supports the path to market. Without the right guidance, critical requirements can be overlooked, leading to avoidable delays, increased costs, and risks to otherwise promising development programs.
RTI serves as a full-service regulatory partner, bridging the gap between innovative science and clinical development readiness. RTI provides clients with a regulatory roadmap that spans the development lifecycle, helping them anticipate regulatory challenges, strengthen development programs, and advance toward first-in-human studies and beyond.
As development programs evolve, this integrated framework provides clients with experienced regulatory support at critical decision points, helping them manage risk, maintain momentum, and build a stronger foundation for successful clinical development and eventual commercialization.
Why Biotech Startups Partner with RTI for Regulatory Consulting
RTI’s multidisciplinary regulatory team includes experts with decades of experience across pharma, contract research organizations (CROs), and the FDA. Our specializations include infectious disease, cardiovascular, pulmonary, hematologic, oncology, and many other fields.
Unlike large commercial CROs where small biotech firms face rotating junior staff and de-prioritization, RTI provides personalized, senior-level attention. Conversely, while academic institutions often focus on publishing research, RTI focuses exclusively on market-ready commercialization and reaching regulatory milestones.
RTI combines the scientific depth associated with a research institute with the development focus and regulatory expertise needed to advance medical products. Small and emerging biotech companies receive personalized, senior-level attention from experts focused on moving programs through critical regulatory milestones and toward commercialization.
Our Regulatory Consulting Background
- Deep Drug Development Experience: Our multidisciplinary team is skilled in regulatory strategy and medical product development, with longstanding relationships across government, industry, nonprofit, and academic organizations.
- Proven IND Track Record: We maintain a high success rate in securing IND clearances by identifying and mitigating risks for clinical holds well before the submission window.
- Client-Aligned Partnership: As an independent, nonprofit research institute, RTI provides objective scientific and regulatory support tailored to each client's technology and development goals. Our role is to complement the client's expertise and help advance products through key regulatory and development milestones.
Meet the Experts
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Diana Severynse-Stevens
Diana Severynse-Stevens
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Lia Gutiérrez
Lia Gutiérrez
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Rebecca Bruning-Barry
Rebecca Bruning-Barry
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Mark Levi
Mark Levi
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Sharon Daily
Sharon Daily
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