Our Story
About Us
BioV8 Life Sciences was founded to help bold scientific ideas reach patients faster — combining regulatory depth with a partnership-first approach.
Founder
Umang S. Shah PhD, MBA, RAC, RPh
Umang S. Shah PhD, MBA, RAC
Umang Shah is a senior Regulatory Affairs executive with more than 30 years of experience guiding pharmaceutical and biotechnology products from early development through global approval and commercialization.
Experience Spanning Small Biotech to Large Pharma, Across Multiple Modalities: He has held regulatory leadership roles at Tanabe Pharma America, Veloxis Pharmaceuticals, Kedrion Biopharma, Shire/Takeda, Merck, GSK Vaccines, Solvay, and Pfizer, leading successful NDA, BLA, 505(b)(2), MAA, and post-approval submissions across small molecules, biologics, plasma-derived therapies, gene therapy, vaccines, immunology, rare diseases, and drug–device and diagnostic combination products.
Broad Expertise Across Multiple Therapeutic Areas: He has extensive experience in the rare and ultra-rare disease space, including orphan drug development, expedited regulatory pathways, global health-authority interactions, and programs involving plasminogen deficiency, Fabry disease, PKU, EPP/XLP, hemophilia, CD28 co-stimulatory blocker to prevent rejection of solid organ transplant, and other high-unmet-need conditions.
Accomplishments: His accomplishments include contributing to the approvals of Creon, Zinplava, Flucelvax, Insulin Glargine, Radicava, and other important therapies; securing a Pediatric Priority Review Voucher; resolving clinical holds and complex FDA review issues; and building and leading high-performing global regulatory teams.
Vision: Through BioV8, he brings an integrated combination of scientific depth, regulatory strategy, health-authority negotiation, CMC expertise, and practical execution to help companies advance innovative therapies efficiently from concept to patients.
Why BioV8 Life Sciences
BioV8 Life Sciences was built on a simple belief: regulatory complexity should never stand between a great therapy and the patients who need it. We bring decades of global regulatory expertise, scientific rigor, and strategic vision to every engagement — from early-stage development through commercial approval and beyond. Our integrated approach ensures that regulatory strategy is woven into the fabric of your program, not treated as an afterthought.
Whether you are navigating a first-in-human study, a complex CMC pathway, or a multi-regional submission, we act as an extension of your team — providing clarity, momentum, and confidence at every turn. We partner with emerging biotechs, mid-size pharma, and academic innovators who share our commitment to transforming science into medicine.
Our People
Our team is composed of former regulators, industry veterans, and scientific specialists who have led programs across every major therapeutic area and global market. We have sat on both sides of the review table — as sponsors, consultants, and agency reviewers — and we bring that multidimensional perspective to every client relationship.
Collaboration is at the heart of how we work. We believe the best outcomes emerge when scientific, regulatory, and commercial teams operate as one. Our consultants are not just subject-matter experts — they are communicators, translators, and problem-solvers who thrive in high-stakes, high-complexity environments.
Experience
Our collective experience spans hundreds of successful regulatory interactions across the FDA, EMA, Health Canada, and major national authorities worldwide. We have supported landmark approvals in oncology, rare diseases, cell and gene therapy, immunology, and beyond — including breakthrough therapy designations, accelerated approvals, and orphan drug designations.
From IND-enabling packages to post-approval lifecycle management, our track record reflects a deep understanding of what it takes to move a molecule from concept to commercialization. We have guided clients through complex scientific advice meetings, pre-NDA/BLA discussions, and regulatory defense strategies — always with a focus on building durable, trust-based relationships with agencies and stakeholders.