regulatory-affairs
(20)
The Agency Built for the Story Nobody Could Yet Explain
Wachsman started with a peculiar bet: the stranger the technology, the more valuable a clear sentence becomes. A decade later, the Bitcoin specialist has become an adviser for companies navigating finance, policy, AI and the expensive business of being misunderstood.
The Firm That Teaches Crypto to Wear a Tie
M Group built its niche in the narrow, consequential gap between a crypto founder's vocabulary and an institution's tolerance for risk. Its product is not publicity alone. It is translation under pressure.
The Russell Group Knows Why Washington's Farm Fights Are Won Before the Vote
For four decades, this Arlington firm has sold a scarce Washington commodity: agreement among people who arrive with different incentives. Its sharpest lesson is simple - build the coalition before you draft the victory speech.
The Small Firm That Knows When Washington Is Still Wet Cement
Smith Garson sells no miracle and owns no factory. It sells timing - the patient work of getting a public project, a grant request or even a definition into the room before Washington's choices harden.
The Zita Group’s Six-Month Lesson in Moving Trenton
A cancer-care bill met resistance, changed shape and became law in less than six months. That compact episode explains the product this woman-owned lobbying firm really sells: knowing what must bend so an idea can move.
Prime Policy Group and the Strange Power of the Right Room
Washington influence is usually described as a business of access. Prime Policy Group’s own casebook suggests something more interesting: the decisive skill is arranging a coalition so that an ignored problem becomes impossible to ignore.
The Small Firm That Sells the One Thing Washington Runs On: Timing
Porterfield, Fettig & Sears built a business around a deceptively simple idea: in Washington, a good argument matters less if it reaches the wrong desk on the wrong Tuesday.
West Coast Advisors knows where the decision gets made
A water agency needs a voice in Sacramento. A dairy coalition needs to explain methane. West Coast Advisors works where technical problems become political decisions.
The Neurologist Who Turned a Failed Experiment Into MEDICOLAB's MRI Bet
A Nagoya neurologist discovered he was better at moving research into the world than producing it at the bench. Eight years later, his 11-person company is using ordinary brain scans to tackle an expensive diagnostic bottleneck.
Celegence Found the Unsexy AI Business: Fixing the Paperwork That Keeps Medicine on the Market
Two sisters started with regulatory services, watched their own writers wrestle with hundred-page reports, and built software around the bottlenecks. The result is a useful playbook for enterprise AI: begin with paid work, reject the clever features that cannot be checked, and automate only what experts can defend.
The Crypto Industry Built Itself a Seat in Washington
Blockchain Association does not sell tokens or write blockchains. It sells coordination - turning a sprawling industry into a voice that Congress, regulators and courts can actually hear.
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.
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.
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.