Healthcare and biotechnology companies are natural fits for SR&ED — much of the sector’s work is, by definition, aimed at resolving genuine scientific and technological uncertainty. The challenge is usually separating eligible experimental development from the regulatory, clinical, and commercial activities that surround it.
Commonly Eligible Activities
- Developing or validating new diagnostic assays, biomarkers, or detection methods where existing techniques don’t achieve the required sensitivity or specificity
- Formulating drug delivery mechanisms to solve stability, bioavailability, or targeting problems existing formulations don’t resolve
- Preclinical experimental work investigating mechanisms of action, dosing behaviour, or formulation stability
- Developing novel laboratory methods or protocols when existing published methods don’t apply to a specific application
What Generally Doesn’t Qualify on Its Own
- Routine clinical trial administration and regulatory submission preparation
- Standard quality control testing using validated, established methods
- Manufacturing scale-up using an already-validated process
- Market research and commercialization planning
A Common Grey Area: Clinical Work
Clinical trials themselves are generally not SR&ED-eligible, but the underlying scientific work — developing new trial methodologies, biomarker analysis techniques, or data analysis approaches needed because standard methods don’t apply — can be, depending on the specific activity.
Documentation in a Regulated Environment
Healthcare and biotech companies often already maintain rigorous documentation for regulatory purposes — lab notebooks, validation protocols, and study records. Much of this same documentation, reviewed with an SR&ED lens, can directly support a claim without significant additional record-keeping.
