About
Our model is intentionally designed for organizations that value clarity, expert judgment, and direct engagement from senior advisors when regulatory decisions carry material business consequences.
Our role is to bring experienced regulatory perspective into decision‑making at critical moments. This approach suits organizations entering decisions that affect investment outcomes, development risk, or market direction, as well as those who are facing regulatory setbacks or agency challenges that require resolution.
For startups, this means clarity before committing scarce resources. For more established organizations, it provides decision‑level regulatory input that supports leadership accountability, external communication, and capital or transaction planning.
Principal Regulatory Strategy & Advisory
Donna DiGangi
Founder and Principal Consultant
Donna founded DiGangi Consulting, LLC in 2003 to provide direct, senior‑level regulatory engagement to clients. She has more than 28 years of experience advising medical device manufacturers, founders, and investors who are navigating complex, high-stakes regulatory challenges.
Throughout her career, Donna has led regulatory strategy and preparation of highly complex medical device submissions across a wide range of technologies, successfully advancing client matters through all levels of regulatory review. Her work includes escalations to senior FDA leadership, up to and including the Commissioner and Chief Counsel, in situations requiring reassessment of agency positions.
Donna has deep experience engaging the FDA in novel and high‑uncertainty contexts, including supporting clients in obtaining Breakthrough Device Designation (BDD) and admission to FDA’s Total Product Life Cycle Advisory Program (TAP). These engagements reflect her ability to align regulatory strategy with clinically meaningful objectives and broader business considerations.
In addition to her regulatory leadership, Donna possesses practical, hands‑on knowledge of manufacturing environments. She has worked globally with high‑technology and medical device companies, collaborating closely with manufacturing partners and technical teams on both product and process. Extensive on‑site engagement with customers and partners worldwide sharpened her judgment in assessing regulatory pathways within real‑world manufacturing and business constraints. Her educational and manufacturing foundation enables close collaboration with R&D teams and the translation of complex scientific and technical data into clear, defensible materials.
Donna holds an M.S. in Civil and Environmental Engineering and a B.S. in Environmental Engineering from California Polytechnic State University, San Luis Obispo (Cal Poly), as well as an M.S. in Quality Assurance. Prior to establishing her firm, Donna held senior managerial roles spanning regulatory affairs, quality assurance, and environmental stewardship, most recently at Kimberly‑Clark Corporation. This background underpins her concise, judgment‑driven approach to regulatory assessment, rooted in a practical understanding of how regulatory expectations intersect with product development, process control, marketing, finance, and enterprise risk.
Regulatory Science & Strategy
Sandya Narasimhan
Senior Consultant
Sandya is a regulatory and technical advisory professional with over 20 years of experience in the medical device industry. By anticipating potential safety and effectiveness questions from regulatory bodies early in the process, she helps clients reduce regulatory risk, strengthen technical documentation, and avoid costly delays.
In navigating the nuances of medical device submissions, Sandya draws on her scientific and research expertise to support clients across regulatory, technical, and cross-functional challenges. Bringing evidence-based insight to regulatory strategy, she evaluates competitor products and analyzes precedent to inform pathway selection and related regulatory decisions, including the refinement of device claims and the regulatory considerations that shape product positioning. She has written white papers for clients, translated complex scientific and technical information for executive and investor audiences, and helped bridge internal gaps between marketing, regulatory, and research and development teams. Her client work has also included clinical monitoring, managing oversight of CRO-run trials, and providing in-person support in hospitals and clinics where client-sponsored evaluations are conducted.
Prior to becoming an independent consultant, Sandya performed bench experiments on human DNA samples and contributed to the Human Genome Project. Transitioning from the lab, she managed the stem cell division at a non-profit organization, coordinating donations of tissue and blood samples to researchers and institutions worldwide. Sandya holds a B.S. in Microbiology and a minor in Biochemistry from The Pennsylvania State University (Penn State), bringing scientific context, clinical relevance, and analytical depth to the firm’s regulatory judgment and diligence work.