Services
Arcstone partners with international life sciences businesses to enter and grow in the U.S. market. We work as an extension of your team – not as outside consultants – to build the capabilities you need on the ground.
Market strategy and intelligence
We take time to understand your company – its history, its experience with international markets, and its goals for the U.S. – and inform your decision with competitive intelligence.
Market feasibility
Before you invest in a US launch, we test whether your product will sell. We analyze competitors, pricing, and customer demand. We tap our network of life sciences investors for their perspective. The goal is to determine if there's a clear US opportunity for your product, device, or drug candidate.
U.S. launch strategy
A detailed plan for your first 18 months in the US market. We specify how to commercialize your product (hospital sales, specialty pharmacy, retail distribution), how to set prices that protect your margins, and how to position your brand for US healthcare buyers.
Location and site selection
Selecting the right state and city for your US operations. We compare taxes, labor costs, and state incentives to identify the best location for your US headquarters, manufacturing site, or distribution center. We work closely with consulates and trade representatives.
Regulatory compliance and legal
We work with our partners to help you build the legal foundation to operate in the U.S.
Incorporation
Creating your official US legal entity. We manage the paperwork to form your US subsidiary (C-Corp or LLC), typically in Delaware. This structure separates your US liability from your parent company.
Registered agent
A required physical address for government correspondence. We provide a Registered Agent to receive legal documents on your behalf. This keeps you compliant with state laws, even without a physical office.
Tax and banking
Obtaining your Tax ID and opening a U.S. bank account.
We secure your Federal Employer Identification Number from the IRS and coordinate with banks experienced in serving international companies to open your corporate accounts.
FDA compliance
We work with the best regulatory consultants to help you navigate the filing process with the FDA, represent you at INTERACT and pre-IND, other meetings.
Supply chain and operational setup
We help you establish compliant logistics for drugs, devices, or diagnostics.
Import and customs
Clearing your products through US customs legally. We manage customs clearance, ensuring you have the correct FDA, CBP import permits and pay accurate duties so your shipments are not delayed at the port.
Logistics and warehousing
Storing and distributing your products to US customers.
We connect you with Third-Party Logistics (3PL) providers who offer Good Distribution Practice-compliant storage, cold chain capability, and fast shipping to US healthcare facilities.
Supply chain architecture
Designing how your product moves from manufacturing to the customer. We map the most efficient routes and distribution points to reduce shipping costs and delivery times while maintaining regulatory compliance.
Commercialization and market access
Understanding who will pay for your product is critical from the start. We help you get that right.
Sales channel development
Identifying partners who will sell your product. We identify and negotiate with US distributors, GPOs (Group Purchasing Organizations), hospital systems, or specialty pharmacies who can place your product in front of prescribers and buyers.
Market localization
Adapting your commercial message for US healthcare buyers. We refine your marketing materials to resonate with US clinicians, payers, and procurement teams – using appropriate clinical language and US healthcare terminology.
Trade show representation
Representing your brand at major US medical conferences. We organize your presence at key events (ASCO, HIMSS, AdvaMed MedTech), from booth logistics to scheduling meetings with potential partners and customers.
Investor relations, business development
We open doors to private equity and venture capital and help you secure the funding you need.
Capital raising advisory
Raising investment from US sources. We help you raise funds through private placements (Reg D) or public offerings (Reg A+), connecting you with family offices, venture capital, and institutional investors focused on life sciences.
M&A preparation
Acquiring a US company or preparing for a future sale. We advise on acquiring US companies to accelerate market entry (inorganic growth) or prepare your US subsidiary for a future exit or strategic partnership.
Fractional CBO
Access to a senior BD executive on a part-time basis. We provide experienced life sciences executives to lead your US partnership discussions, licensing negotiations, and commercial strategy. We identify potential partners, manage deal pipelines, and represent your company in BD conversations.
Local presence and operations
We seek talent or provide U.S. leadership without full-time executive costs.
American Launchpad
A managed service where we execute the entire US setup for you.
We act as your project manager, coordinating lawyers, accountants, regulatory consultants, and logistics providers on a fixed four-month timeline to make you operational.
Fractional executives
Access to a US General Manager on a part-time basis. We provide experienced life sciences executives to represent your brand, sign documents, and manage daily US operations – without the cost of a full-time hire.
Recruitment
Hiring your first US employees when you need them. We help you identify, interview, and hire key US staff (Medical Science Liaisons, Sales Directors, Regulatory Affairs leads), managing US employment law and benefits negotiations