Regulatory affairs and pharmacy software, from Quebec.
Twenty-five years building tools for healthcare. We take your product through Health Canada and the FDA, and we equip community pharmacies with software designed by the people who sit through the inspections.
Most consultancies have read the regulations. We designed products, filed our own dossiers, sat through our own inspections and absorbed our own refusals. When we tell you a procedure will not hold in front of an inspector, it is because we have already been on the other side of that table.
Three lines of work, one discipline
Regulatory affairs
Registrations and licences with Health Canada and the US FDA. Drugs, natural health products, medical devices, software as a medical device, cosmetics. Procedures, quality systems, audits and inspection readiness.
Pharmaflow software
A modular platform for community pharmacies. Policies and procedures, delegation, medication circuit, human resources, expiries, lab accounting. One module at a time, installed without changing everything.
ACTeRX Academy
Continuing education for pharmacy teams, and equivalence exam preparation for pharmacists trained abroad who want to practise in Canada.
Manufacturing outside Canada?
If you make drugs, natural health products, devices or cosmetics in India, Israel, the Emirates, the United States or anywhere else, and the North American market matters to you, the obstacle is rarely the product. It is having someone here who knows what the authority expects and answers in its time zone.
We act as your regulatory arm in Canada and the United States. You do not need an office here to enter this market.
What you can expect
Price before signature. Quoted in writing at first contact, per project or as an annual retainer. Not one Canadian firm we surveyed publishes its rates.
A mandate that starts this week. No queue before the first scoping call.
Handover at the end. Your team is trained on what we put in place. A system nobody can maintain does not survive its first inspection.
What we will not promise
We do not guarantee approval. Registering a product, granting or renewing a licence, and the outcome of an inspection belong to the authority alone. What we guarantee is a dossier that meets the requirements, built on schedule, and a company able to defend it.
We do not provide legal advice either. Our work is regulatory and technical. When a question is a legal one, we say so and work alongside your counsel.
Where would you like to start?
Tell us what you need to register, which pharmacy problem is costing you the most, or simply what your last inspection found.
Ce site est en français: turbo-sbi.com.