Pharmaceuticals

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.

3-day trial · no card · AI included, no setup

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.

Claim the development, not the paperwork

Start a free trial and turn your formulation and process records into a defensible SR&ED claim.

3-day free trial · No credit card required

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.