regulatory-affairs
(15)
Medpace
The Cincinnati CRO built a $2.5 billion business by taking on clinical trials that young biotechs cannot run alone - and by keeping the scientists, software, labs and logistics under one roof.
Enjamb
Enjamb (YC P26) builds full-stack AI agents for biopharma R&D that run a drug program from discovery through FDA approval. Its agents sit on top of legacy pharma systems - Benchling, Veeva, Medidata, SAS - with no migration, doing the work across clinical evidence, trial design, statistical programming, and regulatory submissions while keeping a visible source-to-submission trail. Founded in 2025 by Rayan Mubarak and Maadhav Deekshitha, the San Francisco company raised a $650K pre-seed and says its platform was used by 500+ employees at major pharma firms within weeks of launch.
Ritivel
Ritivel is an AI-native workspace for regulatory and medical writing teams at life sciences companies. Its AI agents draft dense regulatory documents - CTDs, CSRs, INDs, and BLAs - directly in Microsoft Word, following FDA formatting rules and pulling from a company's own clinical data and prior submissions, with every claim cited back to its source. The goal is to compress work that normally takes weeks of manual synthesis into minutes, helping drugs reach patients sooner.
Caroline Shleifer
Caroline Shleifer is the founder and CEO of RegASK, a Singapore-based regtech company that pairs an AI engine built for regulatory content with a global network of 1,800+ subject matter experts. A pharmacist and scientist by training with a PharmD-PhD in medical physics from the University of Paris V, she spent years leading regulatory and scientific affairs across Asia Pacific at SPRIM before founding RegASK in 2018 to bring regulatory work into the AI era.
HiRO - Harvest Integrated Research Organization
HiRO (Harvest Integrated Research Organization) is a full-service, globally oriented clinical research organization founded in 2020 that helps biotech companies run clinical trials across borders. Positioning itself as an 'integrated' rather than a traditional 'contract' research organization, HiRO connects Asian biotechs seeking trials outside their region with US and European sponsors wanting to run studies in Asia. Backed by a tens-of-millions-of-dollars Series A led by OrbiMed and built out through three CRO acquisitions, it offers end-to-end services from preclinical strategy to regulatory submission, with deep expertise in oncology and rare disease.
RegASK
RegASK is a Singapore-based regtech company building an agentic AI regulatory intelligence platform for life sciences and consumer products teams. It monitors regulatory change across 160+ markets, pairs autonomous AI agents with a global community of 1,800+ regulatory experts to validate insights, and automates the workflows that turn regulatory updates into compliant action. Founded in 2018 by Caroline Shleifer, the company raised a $10M Series A in 2022 and in 2025 became the first vertical regulatory intelligence platform certified to ISO/IEC 42001 for AI management.
Fogarty Innovation
Fogarty Innovation is a nonprofit medtech incubator and education organization on the El Camino Health campus in Mountain View, California. Founded in 2007 by legendary surgeon-inventor Thomas J. Fogarty, MD, it helps early-stage medical device companies cross the gap from novel idea to clinical reality through hands-on coaching, education programs, and a network of 300+ industry experts. In October 2025 it merged with New York's Cardiovascular Research Foundation to become CRF's West Coast innovation hub.
RegDesk
RegDesk is an AI-powered regulatory information management platform for medical device, IVD, and pharma companies. It gives regulatory teams 24/7 access to up-to-date requirements across 120+ markets, automates submission-ready applications (GSPR checklists, Essential Principles, Declaration of Conformity), tracks changing regulations with daily alerts, and coordinates distributors - compressing submission work that once took three to six months into roughly a week.
Priya Paul
Priya Paul (Bhutani) is the founder and CEO of RegDesk, an AI-powered regulatory intelligence and management platform for medical device and pharmaceutical companies. A biomedical engineer turned regulatory strategist, she spent years watching life-changing devices stall in regulatory limbo - up to 80% of applications get rejected for reasons unrelated to safety - and built RegDesk in 2014 to compress submissions that once took months into days. She leads the company's product vision and global growth, and RegDesk is a certified Minority Business Enterprise.
COR Medical Ventures
COR Medical Ventures is a San Diego-area medical device development company that acts as the center of rotation for medtech innovation. Through three branches - consulting services, a venture studio, and distribution services - it partners with surgeon-inventors and corporations to take orthopedic, spine, and other devices from clinical idea to FDA clearance and market launch. Founded by engineer Ben Arnold, the firm has stood up a portfolio of more than a dozen independent companies spanning robotics, wearables, spinal fusion, and soft-tissue fixation.
ClinChoice
ClinChoice is a mid-size, global, full-service contract research organization (CRO) that helps pharmaceutical, biotech, medical device, and consumer health companies run clinical trials and bring drugs and devices to market. Founded in 1995 and headquartered in Horsham, Pennsylvania, the firm employs roughly 4,000 people across the Americas, Europe, and Asia-Pacific, offering clinical development, biometrics, safety/pharmacovigilance, regulatory affairs, post-marketing real-world evidence, and technology services. After rebranding from Fountain Medical Development (FMD K&L) in 2020 and raising a $150M Series E in 2022, ClinChoice has grown through acquisitions to serve six of the top ten pharma companies while focusing on emerging and mid-size biotech innovators.
Alvin Luk
Alvin Luk is a biotech executive, neuroscientist and entrepreneur with more than three decades in global drug development. He is President & Chief Medical Officer (Group) and U.S. CEO of HanchorBio, a clinical-stage immunology and immuno-oncology company building Fc-based designer biologics, and co-founder and CEO of CRISPR gene-editing company HuidaGene Therapeutics. Across his career he has contributed to roughly two dozen approved products and more than 250 global regulatory submissions, including LUXTURNA, the first FDA-approved gene therapy. A 2025 TIME100 Health honoree, he wants to turn HanchorBio into the 'Genentech of Asia.'
Benjamin Arnold
Benjamin Arnold is the co-founder and CEO of COR Medical Ventures, a Solana Beach medical-device venture studio that partners with surgeon-inventors and corporations to push the next generation of orthopedic and spine devices to market. A Cornell-trained engineer who has shepherded more than 25 devices to launch, he sits at the 'center of rotation' the company is named for, running a portfolio of roughly a dozen companies spanning surgical robotics, spinal fixation, fracture hardware, and wearable rehab tech.
John Balian
John D. Balian, MD is a physician-turned-executive who co-founded ClinChoice, one of the world's larger full-service contract research organizations, and serves as its CEO, International. He spent years inside the FDA, then ran drug safety and regulatory operations at Pfizer, Bristol-Myers Squibb and Johnson & Johnson before building a global CRO spanning the US, Europe and Southeast Asia. He is also a published novelist whose debut, Gray Wolves and White Doves, draws on his Armenian heritage and the Armenian Genocide.
Moriah Nachbaur
Moriah Katherine Nachbaur is the Chief Business Officer at Pheast Therapeutics, a clinical-stage immuno-oncology company in Redwood City, California, pioneering macrophage checkpoint inhibitors to teach the immune system to destroy cancer cells. Drawing on two decades of cross-functional biopharma experience - from lab benches at Genentech to executive boardrooms at Coherus BioSciences and her own consulting firm MKN Biotech - she brings a rare blend of scientific literacy, operational depth, and strategic vision to one of oncology's most promising new frontiers: the innate immune system's untapped power against solid tumors.