About Us
Our Team
Donna DiGangi
Founder and Principal Consultant
Donna founded DiGangi Consulting, LLC, an independent regulatory consulting practice, in 2003. She brings more than 27 years of experience providing regulatory strategy and guidance to medical device manufacturers, investors, and early‑stage companies navigating complex, high‑stakes regulatory interactions.
Throughout her career, Donna has led the regulatory strategy and preparation of numerous and complex submissions across a wide range of medical device technologies. Her work includes successfully advancing client matters through all levels of regulatory authority review, including escalations to the highest levels of agency leadership. Her experience also includes supporting clients in obtaining Breakthrough Device Designation and admission to FDA’s Total Product Life Cycle Advisory Program (TAP), reflecting her ability to align regulatory strategy with meaningful clinical and business objectives.
Donna possesses deep, practical knowledge of manufacturing operations. She has worked globally with high‑tech and medical device companies, collaborating directly with manufacturing partners and technical teams on both product and process. This work has included extensive on‑site engagement with customers and partners worldwide, informing her ability to assess regulatory strategy in the context of real‑world manufacturing and operational constraints.
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 informs 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 other business realities.
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 from California State University, Dominguez Hills. Her educational and manufacturing foundation enables close collaboration with R&D teams and translation of complex scientific and technical data into clear, defensible materials that support substantiation, compliance, and effective communication.
Sandya Narasimhan
Senior Consultant
Sandya is a Senior Consultant working with DiGangi Consulting, LLC. She has a degree in microbiology and a background in biochemistry, complementing the breadth of the firm’s scientific understanding in addition to regulatory acumen.
Our Personalized Approach
Our work resonates with teams that are moving beyond exploratory discussions and into decisions that shape investment, development, or market direction. It works especially well for those who:
- Prefer direct access to the senior expert doing the work
- Need clear regulatory direction rather than a layered process
- Value candid judgment at each stage of decision‑making
- Want regulatory strategy shaped by the realities of their product and timeline
For startups, that often means clarity on the regulatory options prior to committing scarce resources. For more established organizations, it means decision‑level insight that eases the process and supports accountability at the leadership level. In both cases, the value is the same: robust regulatory strategy delivered directly and aligned with real‑world constraints.
