The biotech sector depends on immigrant talent. More than one-quarter of the U.S. pharmaceutical and medicine manufacturing workforce is foreign born, and over 45% of Fortune 500 companies were founded by immigrants or their children. For biotech founders exploring pathways to build in the United States, understanding the available visa categories and their requirements is a critical first step. Alma's immigration services for individuals help biotech founders identify potential pathways and execute applications with speed, excellence, and care, backed by a 99%+ approval rate and guaranteed 2-week document turnaround.
Biotech founders face unique immigration considerations. Unlike software startups that can operate remotely, biotech ventures often require physical presence for lab work, clinical trials, regulatory meetings, and investor relations. An appropriate visa category must accommodate active business management while providing a realistic path to long-term residency.
The visa landscape for biotech founders falls into three broad categories:
Recent policy developments are relevant to biotech innovators. In January 2025, USCIS updated its Policy Manual with expanded evidence examples for O-1A petitions in critical and emerging technology fields, though the underlying executive order (EO 14110) was revoked on January 20, 2025, and the durability of these guidance changes is uncertain. Separately, immigration authorities have historically approved EB-2 NIW cases at strong rates for pharmaceutical, life sciences, and biotech professionals, though the Chambers 2025 Practice Guide notes that USCIS adjudicators have shown signs of tightening standards in recent months.
The immigration policy landscape has shifted substantially since January 2025. Key developments include:
These developments are evolving rapidly. All processing times, fees, and requirements referenced below are based on publicly available information as of February 2026 and are subject to change.
The O-1A visa has become one of the most widely used visas among tech and biotech entrepreneurs because of its flexibility and absence of lottery risk.
The O-1A category can work well for biotech founders because scientific achievement translates directly to the eligibility criteria:
The visa requires meeting 3 of 8 evidentiary criteria (or demonstrating receipt of a major, internationally recognized award). For biotech founders, commonly cited evidence includes:
With premium processing, USCIS guarantees adjudicative action on an O-1A petition (Form I-129) within 15 business days. This action may be an approval, denial, request for evidence (RFE), or notice of intent to deny (NOID); it is not a guaranteed approval. Standard (non-premium) processing typically takes longer and varies; applicants can check current timeframes at egov.uscis.gov/processing-times. Total end-to-end timelines, including case preparation and any consular processing, may range from 2 to 4 months or more.
The visa is valid for up to 3 years with unlimited 1-year extensions, providing long-term stability for founders building their companies. There is no statutory maximum on total time in O-1A status.
Immigration attorney Sophie Alcorn has noted: "You absolutely can qualify for an O-1A while you're bootstrapping, and VC funding is not required. We've helped many startup founders as well as students get an O-1A even before their startup was generating revenue."
Alma handles O-1 New applications for $8,000, covering attorney fees, paralegal support, platform access, and administrative costs. View the complete pricing breakdown for all visa categories.
For biotech founders seeking permanent residency, the EB-2 National Interest Waiver offers a self-petition option that bypasses employer sponsorship and labor certification requirements.
Biotechnology has historically been among the strongest fields for NIW approval because the work can readily be shown to serve national interests:
The EB-2 NIW requires an advanced degree (master's or higher, or a bachelor's degree plus five years of progressive experience in the specialty) or exceptional ability, plus satisfaction of the three-prong Matter of Dhanasar test demonstrating that the applicant's work:
Biotech founders can demonstrate impact through drug discovery, diagnostic tools, or clinical trials, all areas where individual contribution can be shown to advance national scientific priorities.
Standard NIW processing currently runs approximately 18 to 20+ months, with tens of thousands of cases pending as of late 2025. Premium processing is available for the I-140 petition at a 45 business-day adjudicative action window. Current processing times can be verified at egov.uscis.gov/processing-times. Given these timelines, some founders pursue the O-1A first for work authorization, then file the NIW concurrently for eventual permanent residency.
Alma offers EB-2 NIW services at $10,000, or $7,000 for applicants with an already-approved O-1 visa, recognizing the evidentiary overlap between these categories.
The EB-1A extraordinary ability green card shares evidentiary criteria with the O-1A but leads directly to permanent residency. It is designed for biotech founders and others who are among the top in their field and want a direct route to permanent residency.
Key features of the EB-1A pathway include:
The EB-1A represents the highest-tier employment-based green card category, though it also carries a higher evidentiary bar than the O-1A.
Biotech founders with strong publication records, patents, or significant industry recognition may be strong candidates for EB-1A. The same types of evidence used for O-1A petitions can support an EB-1A petition, though adjudicators generally apply a more rigorous standard when evaluating whether the applicant has risen to the very top of their field.
The H-1B has long been a standard pathway for STEM professionals. The H-1B Modernization Final Rule (effective January 17, 2025) introduced a significant change: founders with majority ownership can now self-petition through their own companies.
The updated rules create new possibilities but come with specific conditions and limitations:
Features:
Conditions and limitations:
Alma's H-1B visa services include $500 for lottery registration and $3,500 for cap or cap-exempt petitions, with guaranteed 2-week document preparation turnaround.
The E-2 visa serves biotech founders who can make a substantial investment in their U.S. venture and hold citizenship from a treaty country.
The E-2 is one of the most commonly used visas for foreign nationals from treaty countries investing in and operating a U.S. business.
Key requirements include:
E-2 features relevant to biotech founders:
The E-2 does not lead directly to a green card, but founders sometimes transition to EB-1A or EB-2 NIW after building their U.S. track record.
The L-1A intracompany transfer visa serves biotech founders who already operate abroad and want to establish U.S. operations.
The L-1A is designed for multinational founders and teams opening U.S. labs, clinical research facilities, or headquarters. Key requirements:
The L-1A offers features relevant to international biotech companies:
New office L-1As receive an initial 1-year approval, extendable up to 7 years total for L-1A holders.
Alma provides L-1 Initial/New Office services at $6,000 and L-1 extensions at $3,000. For businesses managing multiple international transfers, custom enterprise pricing applies.
The TN visa offers Canadian and Mexican citizens a streamlined path for biotech roles that fall within designated professional categories under USMCA (formerly NAFTA).
The USMCA specifies qualifying professions. Biotech-relevant categories include:
Each profession has specific educational or credentialing requirements that must be met. The full list of qualifying professions appears in USMCA Chapter 16, Appendix 2.
The TN process is notably simpler than most other work visas:
Important caveat: TN status does not carry dual intent. Unlike H-1B holders, TN holders must maintain nonimmigrant intent to depart. Extended renewals may raise questions about whether the employment is truly temporary. Founders planning to seek permanent residency should consider this limitation when evaluating the TN against other categories.
For biotech founders whose role fits designated categories, the TN provides a fast, low-cost entry pathway. Alma handles TN applications at $3,000 for new petitions and $2,500 for extensions.
The EB-5 program provides permanent residency for substantial investors. Current investment thresholds under the EB-5 Reform and Integrity Act of 2022 (RIA) are:
Family members including spouse and children under 21 receive green cards alongside the principal investor.
Processing timelines vary significantly by filing type under the current EB-5 framework. For new filings under the RIA: I-526E (Regional Center) petitions are processing in approximately 13 to 14 months; standalone I-526 petitions in approximately 27 to 28 months; and rural TEA projects may process in as few as 6 to 7 months due to set-aside visa availability. Legacy pre-RIA I-526 cases may take 30 to 61+ months. Current processing times can be verified at egov.uscis.gov/processing-times.
The IER provides parole status (not a formal visa or immigrant status) for founders with U.S. backing. Requirements include:
The IER lasts 2.5 years initially, extendable once for a maximum of 5 years total. Re-parole requires meeting additional benchmarks related to increased investment, revenue, or job creation.
Critical caveat: While the IER regulation (8 CFR 212.19) remains codified and the USCIS webpage appears active, the program's practical availability under the current administration is highly uncertain. The program has historically had minimal usage, with only approximately 26 total approvals across its entire existence (FY 2018 through 2023). The current administration has been broadly skeptical of parole-based programs. Founders considering the IER should verify its operational status with USCIS or a qualified immigration attorney before relying on this pathway.
Top accelerator participation can strengthen visa applications across categories:
Alma partners with leading accelerators through its startup immigration plan, offering special pricing for portfolio companies.
Many biotech founders layer multiple strategies:
This layered approach provides redundancy while balancing speed and long-term permanence.
Key timing factors include:
Alma combines experienced attorneys with technology-enabled workflows for high-skilled immigration cases.
Alma's approach addresses the needs of biotech founders:
Unlike firms that bill hourly with unpredictable totals, Alma provides upfront pricing by visa type:
Fees cover attorney services, paralegal support, platform access, and administrative costs. Responses to Requests for Evidence (RFEs) are included at no additional charge.
Interested in exploring your options? Get started with a consultation.
Visa restrictions vary by category. O-1A holders may be able to serve on boards if the activity relates to their extraordinary ability field and does not constitute unauthorized employment. H-1B holders face stricter limits, as board service for compensation generally requires separate authorization. L-1A holders must maintain their primary role with the sponsoring company but may have flexibility for unpaid advisory positions. E-2 holders should ensure any outside activities do not undermine their "directing and developing" requirement for their primary investment. A licensed immigration attorney should be consulted before accepting any board position.
Pre-revenue status does not necessarily disqualify biotech founders from most visa categories. For O-1A and EB-1A, adjudicators focus on the founder's individual achievements rather than company financials. EB-2 NIW petitions emphasize future national benefit, so promising research or pipeline development may suffice. E-2 requires demonstrating the investment is "substantial" relative to the business type, and a lab-intensive biotech may present different revenue expectations than a services business. The International Entrepreneur Rule specifically targets early-stage companies and focuses on funding rather than profitability.
Acquisition triggers different consequences depending on visa type. O-1A and EB-2 NIW self-petitioners maintain status independently of any employer. H-1B holders typically need the acquiring company to file an amended petition or new H-1B. L-1A status depends on maintaining the qualifying corporate relationship; if the foreign parent sells, L-1A eligibility may be affected. E-2 treaty investor status requires continued investment and control, so a full acquisition typically ends E-2 eligibility unless the investor begins a new qualifying investment. These situations are fact-specific and an immigration attorney should be consulted.
While no visa category targets orphan drug development specifically, this focus can strengthen applications across categories. EB-2 NIW petitions may benefit from rare disease work because it can clearly be shown to serve national health interests, often with a limited pool of alternative researchers. O-1A applicants may cite FDA Orphan Drug Designation as evidence of the significance of their contributions. Grant funding from NIH or disease-specific foundations may support IER eligibility (subject to the program's availability). The combination of scientific importance and limited competition in rare disease research can produce compelling immigration cases.
