Services

Low production rates are rarely a single-cause problem. I conduct a structured analysis of your manufacturing operation — equipment utilization, batch scheduling, changeover times, material flow, and staffing patterns — to identify where output is being lost.

From there, I develop and implement targeted improvements: revised batch records, optimized equipment sequences, adjusted in-process controls, and practical scheduling changes that your team can sustain. The goal is a measurable increase in throughput that holds up under GMP scrutiny — whether your next inspection is Health Canada or FDA.

Over time, pharmaceutical manufacturing processes accumulate unnecessary steps — redundant checks, over-engineered controls, legacy procedures that no longer reflect how the operation actually runs. This complexity slows production, increases the risk of deviations, and makes training harder.

I map your current processes end-to-end, identify what's adding friction without adding value, and redesign workflows to be leaner and more reliable. Simplified processes are easier to execute correctly, easier to train on, and easier to defend during a Health Canada or FDA inspection.

GMP compliance is the foundation everything else is built on. I conduct thorough gap assessments against Health Canada's Good Manufacturing Practices guidelines, FDA 21 CFR Parts 210/211, and ICH Q10 — identifying where your operation is exposed and what needs to change.

I then work with your team to close those gaps — updating SOPs, revising batch records, strengthening in-process controls, and building the documentation structure that demonstrates compliance to either agency. The result is a facility that's genuinely compliant, not just inspection-ready on paper.

Navigating regulatory submissions requires both agency-specific knowledge and a thorough understanding of your manufacturing operation. I prepare and manage Health Canada filings — Drug Establishment Licences, New Drug Submissions, and Abbreviated New Drug Submissions — as well as FDA submissions including ANDAs and related CMC documentation.

I coordinate the compilation of required documentation, review submissions for completeness and consistency, and manage responses to agency queries. My goal is a clean, defensible submission that moves through the review process efficiently — regardless of which regulator is on the other side.

A quality system that exists only in binders doesn't protect your operation. I design and implement quality frameworks that are practical for your team to use daily — change control, CAPA, deviation management, document control, and annual product reviews that are proportionate to your operation's size and risk profile.

Where existing systems are in place, I assess their effectiveness and identify gaps. Where systems need to be built, I develop them with your team so they understand and own the process — not just follow a procedure someone else wrote. The result holds up whether the auditor at your door is from Health Canada or the FDA.

An inspection is not the time to discover gaps in your operation. I conduct mock inspections that mirror the structure and focus areas of a real GMP audit — whether you're preparing for Health Canada, the FDA, or both. Facility walkthrough, documentation review, records sampling, and staff interviews are all part of the process.

Following the mock inspection, I provide a detailed findings report with prioritized corrective actions. I then work with your team to close those findings before the real inspection, ensuring you go in with genuine confidence rather than hope.