SR&ED for pharmaceuticals
Pharma does a lot of SR&ED beyond the discovery bench, in the work of turning a molecule into a stable, manufacturable product. That formulation and process development is often eligible, and often overlooked, because it sits right next to a mountain of routine and regulatory work.
The eligible part is where the technological outcome was uncertain — not the confirmation or the compliance around it.
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Where the eligible work usually is
- Formulation and drug-delivery work where release, stability or bioavailability couldn't be predicted and had to be solved experimentally.
- Manufacturing and CMC scale-up where moving from bench to production volume introduced genuine unknowns.
- Developing a new analytical or process method because the established ones couldn't do what you needed.
- Reformulating to hold efficacy while changing an ingredient, form or process, where the outcome was uncertain.
What usually doesn't qualify
Routine quality control, standard analytical testing to a known method, bioequivalence work that confirms an expected result, regulatory dossier preparation, and GMP production the established way generally aren't SR&ED. Clinical operations and trial management sit outside the eligible line too, even though they're essential.
Evidence from development
Pharmaceutical development leaves detailed records: formulation and stability trials, dissolution and analytical data, method-development results, and batch records. Upload them and SREDlog organizes them against the project, keeping the link between a claimed cost and the experiment that supports it — the traceability a review will test.
Frequently asked questions
Usually not in itself. Much clinical and regulatory activity confirms safety and efficacy rather than resolving a technological uncertainty. Earlier experimental development, like formulation or process work, can be eligible.
It can be, where achieving the same performance through a different formulation or process required experimentation with an uncertain outcome, rather than applying a known method.
There's overlap. Biotech tends to cover discovery and biological uncertainty; the pharma line here is more about formulation, delivery and manufacturing. See SR&ED for biotechnology.
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This guide is general information, not tax advice. SR&ED rules, rates and limits change, so confirm the current figures with the CRA or your advisor before you file.