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R&D Tax Credit for Life Sciences / Biotech

Drug discovery, diagnostics & lab automation

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Why Life Sciences / Biotech companies qualify

Discovery, assay development, scale-up, and device design are inherently experimental, with substantial uncertainty about efficacy, performance, and reproducibility.

The credit is calculated on qualified research expenses (QREs) — primarily wages for engineers and technical staff who spend time on qualifying activities, plus supplies, cloud/compute, and 65% of qualified contract research.

Qualifying activities in Life Sciences / Biotech

The table below lists the business components that most often qualify, a common example, and the technical uncertainty that makes each one defensible.

Business componentExampleTechnical uncertainty
Drug discovery & formulation Novel compound, formulation, or delivery system Will the candidate achieve efficacy and stability?
Assay & diagnostic development New assay or point-of-care diagnostic Can it hit sensitivity and specificity targets?
Bioprocess & scale-up Fermentation or cell-culture scale-up Will the process scale while holding yield and purity?
Medical device development Implant, instrument, or wearable Will the device meet safety and performance under use?
Lab automation & software LIMS, automated screening, analysis pipeline How to automate workflows reliably and reproducibly?
Analytical method development New chromatography or mass-spec method Can the method reliably quantify the target?
Computational / genomic biology Variant-calling pipeline, predictive model Which model or pipeline yields valid predictions?
Process & manufacturing tech New sterilization or packaging approach Will it meet sterility and shelf-life requirements?

Potentially qualifying example

A team tests candidate buffer and assay conditions to resolve whether a diagnostic can retain sensitivity after storage. The experimental formulation and analysis may qualify when tied to a defined business component.

Usually outside the credit

Routine lot-release testing, running an established assay, and regulatory paperwork generally are not experimental development. Grant- or sponsor-funded work may also be excluded when payment is assured regardless of outcome and the company lacks substantial rights; agreements matter.

Role and activity map

Find your own job titles below. Each row shows the wage category a role usually falls under and the kinds of work that typically do and do not count. Titles alone never make wages eligible; the activity must meet the four-part test.

7 of 7 roles shown

RoleWhat they doWage categoryTypically qualifiesTypically does not
Designs experiments to see whether a scientific approach works. Direct research Testing biological mechanisms, Experimental assay design +1 more Literature summaries alone, Routine established assays +1 more
Develops and tests compounds or formulations against technical requirements. Direct research Experimental synthesis routes, Formulation stability trials +1 more Routine batch release, Known formulation replication +1 more
Finds a reliable way to produce a biological product. Direct research Experimental culture conditions, Uncertain purification methods +1 more Routine commercial batches, Standard equipment operation +1 more
Builds computational methods for scientific experiments. Direct research Experimental analysis algorithms, Uncertain data-processing methods +1 more Routine analysis using known tools, Dashboard maintenance +1 more
Prepares and runs experiments for the research team. Direct support Preparing experimental samples, Recording results from qualifying trials +1 more Routine diagnostic testing, General lab cleaning +1 more
Collects measurements used to evaluate experimental designs. Direct support Trial-specific measurement setup, Comparative experimental testing +1 more Routine quality-control release, Regulatory submission administration +1 more
Directly supervises the people performing scientific experiments. Direct supervision First-line experimental direction, Reviewing technical alternatives +1 more Grant administration, Investor updates +1 more

Wage categories follow IRC Section 41. Only the portion of time spent on qualified research counts, and the percentage must be documented.

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Example credit scenario

Illustrative first-year ASC calculation

Qualified W-2 wages$500,000
Supplies$5,000
Cloud & computer rental$20,000
Contractor research spend$100,000
↳ 65% statutory haircut (IRC §41(b)(3))$65,000
Total QRE$590,000
Illustrative first-year ASC credit (6%) ≈ $35,400

Illustrative example using sample figures. Your actual credit depends on your facts; see Form 6765 and consult a tax professional.

The four-part test applied to Life Sciences / Biotech

The IRS requires qualifying research to satisfy four tests. Here's how they typically map for this industry:

Permitted purpose

The activity aims at improving a product, process, software, or technique used in the business — not just a business outcome.

Technological in nature

The work relies on principles of engineering, computer science, biology, chemistry, or another hard science to resolve uncertainty.

Elimination of uncertainty

There was genuine uncertainty at the outset about whether — or how — the component could be built or improved.

Process of experimentation

The team evaluated alternatives: A/B tests, prototypes, benchmarks, simulations, or iterative design-build-test cycles.

Three steps to identify eligible time

  1. Name the project, not the person. What were you trying to build or improve, and what did you not know when you started?
  2. List who touched it. Who built it, who directly supervised them, who tested or supported it.
  3. Put a band on it, then back it into evidence. Pick a range, not an exact number, then name where it comes from: tickets, sprints, time entries, commit history, design docs, incident reports.

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Questions to ask your team

Take these into a 15-minute conversation with your team.

  1. Who do you ask when you need something designed or built internally? Ask it twice: once about products and features, once about the production or delivery process.
  2. Who is that person's direct supervisor, and does that supervisor review the technical decisions?
  3. Does anyone report to that person?
  4. Which employees do you turn to when something is broken and nobody knows why?
  5. Which project did you start without knowing whether it would work?
  6. Who was in the room when you decided how to build it?
  7. Who ran the test, build or pilot and wrote down the results?
  8. Was any of this paid for by a customer or a grant, and did anyone outside the US work on it?

The last question matters most. Customer-funded work and work performed outside the US are generally excluded. Funded work is excluded to the extent your business does not bear the financial risk or does not retain substantial rights in the results.

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Frequently asked questions

Does a failed research program still qualify?

A successful commercial outcome is not required. The activities must still meet the research criteria, and records should show the alternatives tested and results.

Are clinical or laboratory studies automatically eligible?

No. Eligibility depends on the specific activities, technical uncertainty and applicable exclusions. Routine testing, data collection and regulatory administration need to be separated from qualified research.

Can grant-funded work count?

Review the agreement to determine who bears the financial risk and retains substantial rights in the results. Grant or customer funding can exclude expenses, so funding alone should not be treated as proof of eligibility.

Can U.S. contract research organizations be included?

A portion of eligible contract research expenses may count when the contract-research requirements are met. Review performance location, economic risk and retained rights for each agreement.

Do research supplies and equipment count?

Nondepreciable materials consumed in qualified research may qualify as supplies. Depreciable laboratory equipment is generally not a qualifying supply expense.

What should we save from each project?

Keep protocols, lab notebooks, experimental results, design decisions and time-allocation support. Link costs to the research performed and retain the relevant funding agreements.

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See how much your Life Sciences / Biotech team qualifies for

Most companies underestimate what they can claim. Our study covers every qualifying role, every component, and every year still open for amendment.

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