SR&ED for pharmaceuticals
One pharmaceutical program can contain formulation experiments, routine analytical work, GMP production and regulatory preparation.
Treating the entire program as one kind of work obscures the claim boundary.
Start with the unresolved scientific or technological question. Then follow the experiments and conclusions separately from confirmation, production and compliance activity.
Follow the formulation or process uncertainty
- Formulation or delivery experiments where release, stability or bioavailability could not be predicted from available knowledge.
- CMC scale-up work where moving beyond the bench changed the process behaviour in an unresolved way.
- Analytical or process-method investigations undertaken because established methods could not achieve the required result.
- Reformulation work where a changed ingredient, dosage form or process produced an uncertain technical response.
Do not treat the whole development program alike
Routine quality control, testing by a known analytical method, dossier preparation and GMP production by established methods generally fall outside SR&ED. Clinical, bioequivalence and other testing need a fact-specific review. They may be support work only when they directly support and are commensurate with eligible experimental work.
Put the hypothesis beside the batch record
Formulation tables, stability and dissolution results, method-development data and batch records can show the investigation in detail. The batch record tells you what happened; the hypothesis and conclusion explain why that run mattered.
SREDlog organizes approved development records against the project and connects reviewed costs to the relevant experiments.
Frequently asked questions
Keep reading
Review a pharmaceutical SR&ED project
Start a free trial and organize one project's formulation trials, analytical data and reviewed costs.
7-day free trial · No credit card required
These industry examples are prompts for a fact-specific review, not categories guaranteed to qualify. Work must be conducted in Canada and meet both current CRA requirements; support work must directly support and be commensurate with eligible work. This is general information, not tax advice, and has not been reviewed by an independent qualified tax professional. See our editorial policy.