Unparalleled Experience

We are built on deep experience and a proven history of success in the global life sciences industry. Founded in 2024 by Leonel Vanegas, a seasoned executive with more than 25 years of pharmaceutical, biotechnology, medical device, and combination product experience, our organization combines unmatched knowledge of the subtleties of today‘s regulatory and quality landscape.

Leonel and his team have worked with biotechs from early-stage to multinationals across two and a half decades. From facilitating FDA pre-submission meetings to EMA scientific advice preparation, to refining the quality management system (QMS) or constructing audit-ready processes, Precision Regulatory Consulting has helped clients achieve regulatory success without sacrificing operational flexibility.

We specialize in regulatory routes and quality frameworks for

• Pharmaceutical Products

• Biologics and Biosimilars

• Medical Devices (Class I-III)

• Drug-Device Combination Products

• In-Vitro Diagnostics (IVDs) and Companion Diagnostics

• Digital Health Technologies and Wearables

We build our work on a thorough understanding of global regulations — from FDA, EMA, and Health Canada to the emerging markets. We combine this understanding with a collaborative culture, acting as true partners to clients, helping them address today’s regulatory challenges and prepare for tomorrow’s. Unlike the big consulting firms where you would be just one of many projects, we pride ourselves on providing personalized, tailored service. All projects are managed by senior level professionals and Leonel himself is directly involved, so you get experienced guidance every step of your product life cycle.

Precision Regulatory Consulting provides added value in a scalable, template-driven process — allowing customers to reap efficient, reproduceable solutions and yet respond to the unique needs of every product and market.

We are particularly interested in helping small to medium-sized businesses with limited in-house capacity. Our ideal client size is 2-5 products in the clinic or 5+ products commercially available with quality as a strategic differentiator and compliance as the route to long-term growth.

With mentorship, innovation, and an unwavering commitment to quality, Precision Regulatory Consulting LLC is ready to lead you through the ever-evolving regulatory environment — and to secure better healthcare outcomes for those patients.