+ Life Sciences
FDA pathways, clinical infrastructure, NIH funding, and regulatory credibility — ATA builds the full U.S. entry stack for biopharma, medtech, and diagnostics companies.
The Challenge
The U.S. life sciences market is the world's largest — and its most regulated. FDA approvals, clinical trial infrastructure, IP strategy, and government funding access all require a U.S.-rooted presence that most international companies build too late.
The FDA's drug, biologic, and device approval processes — IND, NDA, BLA, 510(k) — require a U.S.-based regulatory contact, specific submission formats, and deep familiarity with agency review cycles. Foreign companies routinely lose 12–18 months navigating this alone.
Running a U.S. clinical trial requires IRB approval, CRO relationships, site contracts, and GCP compliance — all with U.S.-based oversight. International sponsors without a U.S. regulatory presence face immediate barriers.
Life sciences IP strategy in the U.S. — patent prosecution, exclusivity periods, orphan drug designations, licensing — requires coordination between regulatory strategy and legal counsel that most foreign companies lack.
SBIR/STTR grants, NIH funding mechanisms, and BARDA contracts represent billions in accessible capital for innovative life sciences companies — but require a U.S. entity, U.S. PI relationships, and a specific grant-writing infrastructure.
How ATA Solves It
ATA delivers the regulatory, legal, clinical, and commercial infrastructure for life sciences companies entering the U.S. market. We work with FDA regulatory consultants, IP attorneys, CROs, and NIH grant specialists to get you registered, funded, and in front of the right institutional partners.
From SBIR/STTR grants to BARDA and NIH contracting, we also open the government health procurement pathway — the most capital-efficient entry point for innovative life sciences companies.
FDA Regulatory Strategy
IND, NDA, BLA, 510(k) pathway mapping, pre-submission meetings, regulatory contact setup
Legal & Entity
U.S. entity formation, IP assignment, licensing agreements, tech transfer structure
Clinical Infrastructure
IRB coordination, CRO introductions, site contracting support, GCP compliance framework
Gov. Procurement & Grants
SBIR/STTR, NIH grant strategy, BARDA and DoD health program access
Credibility & Advisory
U.S. scientific advisory board placements, KOL introductions, association memberships
Go-to-Market
Payer strategy, hospital system sales, reimbursement pathway, commercial launch planning
Regulatory Map
Investigational New Drug Application
Required before initiating clinical trials in the U.S. for new drugs or biologics. The IND establishes a regulatory relationship with the FDA and defines the clinical development plan. Foreign sponsors must designate a U.S. agent.
New Drug Application / Biologics License Application
The formal pathways for FDA approval of new drugs (NDA) and biological products (BLA). Each requires clinical evidence, manufacturing data, and labeling — a multi-year process requiring full U.S. regulatory infrastructure.
Good Clinical Practice
The international quality standard for designing, conducting, and reporting clinical trials. FDA-regulated trials must comply with 21 CFR Parts 50, 56, and 312. Non-compliance invalidates trial data — a critical risk for foreign sponsors.
Institutional Review Board
Required for all U.S. human research. IRBs review and approve study protocols to protect participant rights and safety. Selecting the right IRB — central vs. local — affects trial timelines significantly.
Small Business Innovation Research / Technology Transfer
Federal programs awarding non-dilutive grants across NIH, NSF, BARDA, and DoD. Require a U.S.-registered entity and often a U.S.-based Principal Investigator. Represent one of the most accessible funding sources for early-stage life sciences companies.
Good Manufacturing Practice
FDA regulations governing the manufacturing, testing, and quality assurance of drugs and biologics. U.S. commercial production requires FDA-registered facilities and GMP compliance — a prerequisite for approval and market launch.
Other Industries
Get Started
FDA-registered. Clinically credible. NIH-funded. One engagement.
