Our Services
Regulatory expertise, handed back to you.
Adroit-Metis LLC is a life sciences regulatory strategy and technology firm. We combine deep regulatory expertise with purpose-built technology platforms to move biopharma, medtech, and life sciences programs forward: faster, smarter, and with full ownership handed back to our clients at every step.
Smarter PATH™ Suites
Methodology-driven platforms, built on the PATH framework.
Pre-Work, Architecture, Tools, Handoff. Our flagship platforms are built on the proprietary PATH framework and designed so every engagement ends with complete client ownership, not vendor dependency.
Suite 01
Smarter PATH™ to Approval
Regulatory strategy and submission-readiness support that structures the path from development milestones through approval, with a full suite of tools spanning every phase of the process.
Suite 02
Smarter PATH™ to Investing
Strategic and diligence-oriented tools that help sponsors and investors evaluate, structure, and de-risk life sciences investment decisions.
Suite 03
Smarter PATH™ to Risk Management
Global risk management program architecture covering REMS (US), RMP (EU), and risk management frameworks for the rest of the world. We convert risk management into strategy management.
Full-Service REMS
Smarter PATH™ to Risk Management designs the program. For sponsors who need it operated as well as architected, we deliver the full operational layer under Adroit-Metis oversight and reporting.
01ETASU development, implementation and support. Elements To Assure Safe Use, built and operated as part of the program rather than bolted on afterwards.
02Prescriber and pharmacy outreach. Certification, enrollment and education contact across institutional and specialty settings.
03Specialist live agent teams. US-based agents with clinical and pharmaceutical backgrounds.
04Multi-channel outreach. Coordinated phone, email and digital contact rather than a single channel repeated.
05Stakeholder portals and dashboards. For ease of operations and increased compliance across every party to the program.
06FDA aligned system design. Built to meet current and future regulatory expectations, with efficiency, compliance and cost reduction at its core.
07Fully integrated call center. A high technology, low cost option integrated directly into the program rather than run as a separate vendor.
08Assessment Report and Knowledge Assessment support. Preparation, execution and submission support for the assessments the program is judged on.
09Inspection readiness support. Documentation, evidence and process discipline maintained so readiness is continuous, not a scramble.
10Integrated electronic prescribing. e-Prescribing built directly into the platform, so prescribing, certification status and dispense authorization operate within a single all-inclusive workflow.
Our system accomplishes the goals set forth in the FDA CodEx initiative, and is the premier choice in full service, integrated REMS administration support today, for individual and shared REMS alike.
Eliminating the quality concerns and exorbitant cost associated with legacy options, Smarter PATH™ to Risk Management is truly fresh air in a very heavy space. It is led by some of the industry's most innovative subject matter experts, people with the lived experience of stagnant solutions that keep building on yesterday's mold of high activity cost.
That depth extends well beyond the platform. Adroit-Metis brings extensive experience in regulatory agency engagement support, preparing sponsors for and guiding them through agency interactions on program design, modification and assessment. We pair that with strategic guidance that treats risk management as part of the commercial plan rather than a cost of doing business, and with active industry collaboration alongside the organizations working to advance innovation in the REMS space.
We always knew there had to be a better way, and we were right.
Platforms
Purpose-built products, not repurposed software.
Three platforms, each built for a problem the industry has been solving by hand.
Quality Management
Veros
Not your average QMS: a full closed-loop quality chain, including nonconformance, CAPA, change control, controlled documents, training, audits, suppliers, and risk, under one compliant control layer.
Then it adds two things most quality systems do not have: an advisory AI that respects the compliance model, and a collaboration layer that captures the reasoning behind your decisions as reusable corporate knowledge.
Rare Disease Intelligence
Spoor
Tracking the path of rare disease.
A rare disease intelligence platform built for sponsors, investors, and advocacy stakeholders navigating the rare disease landscape. Patient, observant, and quietly relentless in surfacing the insights that matter.
Women's Health Intelligence
Beyond Bikinis
A global women's health intelligence platform built on a "Women as Default" thesis, helping organizations identify and close gaps in sex-specific research, funding, and reporting across the global health landscape.
The Veros Engagement Model
01Assessment & Gap Analysis
02Architecture & Design
03Implementation & Integration
04Governance & Audit Readiness
05Ongoing OptimizationOptional advisory
Regulatory Strategy Consulting
Direct, hands-on, built around your program.
Beyond our platforms, our team provides regulatory strategy and technology consulting for biopharma sponsors, private equity and venture investors, and life sciences organizations. Tailored engagements built around each client's specific program needs.
Fractional Leadership
Senior expertise, without the full-time overhead.
Experienced, on-demand executive leadership for organizations that need senior capability now. Available across:
Quality Assurance
Pharmacovigilance
Regulatory Affairs
Risk Management
GCP
GMP
