Certara USA Inc.

Certara USA Inc., headquartered in Radnor, Pennsylvania, sells biosimulation software, regulatory analytics tools, and specialized consulting services to federal health and defense agencies as a prime contractor, with no sub-award footprint. The vendor competes exclusively in full-and-open procurements; no set-aside categories appear across its recent federal work.

Certara's core federal capability centers on proprietary modeling, simulation, and data-management software for drug development and regulatory review. The vendor's primary products—Phoenix WinNonlin, Certara Phoenix, CHEMOFFICE, SEND Explorer, and Pinnacle 21—enable federal scientists and regulators to conduct clinical pharmacology, pharmacometric, and regulatory analyses on biopharmaceutical submissions. Representative recent work includes a $2.06 million firm-fixed-price purchase order from the Food and Drug Administration (awarded September 28, 2026) for datafit operations and maintenance through 2029; an $845.8 thousand FDA purchase order (July 2023) for Phoenix licenses and combination software tools supporting the Office of Clinical Pharmacology's drug-review function; a $2.14 million National Institute on Drug Abuse labor-hours purchase order (September 2022) for toxicology consulting services to neuroscience-focused drug discovery programs across NINDS, the NIH Blueprint Neurotherapeutics Network, and the HEAL Initiative; and a $1.50 million Defense Health Agency delivery order (September 2022) under the GSA Multiple Award Schedule for Pinnacle 21 enterprise software, maintenance, and training through 2027.

Customer concentration is weighted heavily toward HHS agencies, particularly the FDA and NIH institutes. The top five customer agencies account for 49% of awards by count and 94% of combined potential value. The FDA leads on award count (5 awards, $3.6 million combined potential value) and ranks first on potential-value basis as well. The National Institute on Drug Abuse holds the second rank (4 awards, $2.2 million), followed by the Defense Health Agency (1 award, $1.5 million), the CDC Pittsburgh location (1 award, $749 thousand), and GSA Federal Acquisition Service (1 award, $475 thousand). The vendor's customer base spans 16 distinct agencies but concentrates sharply on civilian health-research and regulatory missions rather than DoD or civilian procurement.

Certara places two task orders under the GSA Multiple Award Schedule, totaling $2.1 million in combined potential value. No other parent vehicles appear in the recent footprint, and the vendor does not sit on GWACs or IDIQs. The vendor operates as a pure prime; the award portfolio shows 39 prime awards and zero sub-awards. Award activity has remained modest and relatively flat: five awards in 2022, six in 2023, six in 2024, one in 2025, and two in 2026 (the source data snapshot extends through October 15, 2026). Combined potential value across all awards stands at $9.1 million, with $4.2 million obligated to date. Four awards with ultimate completion dates in the next twenty-four months carry $3.2 million in combined potential value and face recompete exposure.

Service Contract Inventory data show minimal federal services engagement above the $150,000 reporting threshold: four prime SCI records across FY2022–FY2025 with zero invoiced revenue reported (SCI captures only service contracts; Certara's software license and purchase orders dominate the federal footprint and fall outside SCI scope). The SCI dataset shows negligible FTE delivery—1.8 FTEs in FY2025 across one prime and two subcontractor records—reflecting that Certara's federal model is software-centric rather than services-labor-intensive. The vendor maintains active GSA Schedule labor rates spanning software developers ($104.66/hr), data fitness analysts and business analysts ($109.64/hr), CDISC subject-matter experts ($147.52/hr), and solutions architects ($164.47/hr), all requiring bachelor's degrees with 3–7 years of experience and no security-clearance mandates.

Certara is a corporate parent with four named subsidiaries: Pinnacle 21 LLC, Synchrogenix Information Strategies LLC, Pharsight Corporation, and international entities Certara UK LIMITED and Certara France SARL. Pinnacle 21 represents a meaningful sub-portfolio within the corporate footprint—the Defense Health Agency's $1.5 million Pinnacle 21 enterprise award underscores that subsidiary's regulatory-data-standards market position. The vendor has maintained federal relationships since at least 2003 and operates across Wayne, Pennsylvania; Princeton, New Jersey; and Frederick, Maryland as primary performance locations, with ancillary work in Silver Spring, Maryland and Calverton, Maryland.