Drug manufacturers in Canada operate under the Food and Drug Regulations, Part C, Division 2, and Health Canada’s Good Manufacturing Practices guide for drug products. Many Ontario sites also supply the United States, which brings FDA 21 CFR Parts 210 and 211, and Part 11 for electronic records, into the same project.
Our pharmaceutical consulting work sits where those requirements meet the production floor. We write and execute the IQ, OQ and PQ protocols, qualify equipment moved between lines or sites, validate the computerized systems that control it, and keep facility documentation current, so your quality unit has evidence it can approve and an inspector can follow.
We work as an extension of your engineering and quality teams rather than at arm’s length, whether the job is a single piece of equipment or a full packaging line.
Each service can be scoped as a fixed deliverable or as embedded support on a capital project.
Risk-based qualification protocols, execution, and summary reports for new and modified process and packaging equipment.
Requalification of equipment relocated between rooms, lines, or sites, scoped to what actually changed.
Bottling and packaging lines qualified as an integrated system, whatever equipment the line is built from.
CSV for PLC, HMI, SCADA and packaging control systems, with a data-integrity focus.
GMP facility layouts, expansions, and the as-built documentation that keeps them inspection-ready.
Gap assessments and remediation ahead of Health Canada or FDA inspections.
Solid oral dose (tablets and capsules), oral liquids, and topical products, together with the primary and secondary packaging lines that serve them: bottle counting and filling, blister and stick-pack lines, induction sealing, labeling, cartoning, and serialization.
Our engineers qualify process, packaging, and utility equipment of every type, from single standalone units to complete integrated lines. Recent work includes performance and transfer qualification of a pharmaceutical bottling and packaging line in Ontario. Read the project summary.
We review your process, equipment list, timelines, and regulatory drivers, and agree on what a finished deliverable looks like.
A fixed-scope proposal or embedded-support plan, with the validation approach, deliverables, and milestones set out before work starts.
Our engineers write and execute protocols, documentation, and engineering packages alongside your operations and quality teams.
Summary reports, deviations resolved, and a documentation package your quality unit can approve and an inspector can follow.
Tell us about the equipment, the timeline, and the regulator. We will respond with a practical next step.
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