Your SOPs are already written. What is left is fitting them to you.
We build, file and defend regulatory submissions with Health Canada and the US Food and Drug Administration. Price quoted before you sign, mandate that starts this week, and a team in Quebec that answers during your business hours.
If you manufacture outside North America
Your product is not the problem. The problem is that entering Canada or the United States requires someone on the ground who speaks the regulator’s language, knows its unwritten expectations, and replies inside its time zone.
That is what we do. We act as your North American regulatory arm: we assemble the Canadian or US dossier, we carry the correspondence with the authority, and we hand back a documentation set your own team can maintain. You do not need to open an office here to reach this market.
We currently support manufacturers based in India, Israel, the United Arab Emirates and the United States, alongside our Canadian clients.
Three ways to start
Regulatory diagnostic
You do not know where you stand
- Product classification and applicable framework
- Review of your existing documentation
- Gap list, ranked by severity
- Costed remediation plan
You keep the report, whether or not you continue with us.
Submission mandate
You have a product to register
- Full dossier assembly
- Filing and follow-up with the authority
- Responses to deficiency notices included
- Procedures and records the dossier requires
Fixed price at quote, not an hourly rate that drifts.
Annual retainer
You need to stay compliant over time
- Monitoring of rules that affect your products
- Maintenance of your documentation set
- Annual licence renewals
- Inspection support
- Advisory hours included
A known annual figure, not an invoice that surprises you.
Get a price
See the SOP library
What we handle
Registrations and licences
Drugs, natural health products, medical devices, software as a medical device, cosmetics. Dossier assembly, filing, responses to deficiency notices, annual maintenance.
Procedures and documentation
Writing and revising your standard operating procedures, policies, forms and records, aligned with the framework that governs your activity rather than a generic template.
Quality and audits
Quality management systems, internal audits, supplier audits, inspection readiness, deviation handling, corrective and preventive actions, management review.
Vigilance and post-market
Adverse event reporting, recall management, complaints, post-authorization changes, and monitoring of regulatory updates that touch your products.
The deadlines that concern you, each with its source
We do not manufacture urgency. These are real. Each one links to the instrument that creates it, so you can verify without taking our word for it.
Already in force
| Since | What changed |
|---|---|
| 1 August 2026 | Fragrance allergen List 2, which takes disclosure to 81 entries, applies to new cosmetics. Products already on the market have until 1 August 2028. Thresholds unchanged: 0.01% for rinse off, 0.001% for leave on. Health Canada, labelling of cosmetics |
| 15 July 2026 | Good news rather than a constraint. The order providing for reliance on decisions of foreign regulatory authorities opens accelerated filing routes and joint reviews for certain drugs. If your product is already authorized by the FDA or the EMA, your Canadian file no longer starts from zero. SOR/2026-162 |
| 12 April 2026 | Fragrance allergen List 1, 24 substances, applies to both new and existing cosmetics. This is the deadline that reached stock already in circulation, and the one we most often see missed. SOR/2024-63 |
| 4 March 2026 | Version 4.0 of Health Canada’s good manufacturing practices guide for natural health products, GUI-0158, applies. Published 4 September 2025 with a six month transition. It reorders the text to follow Part 3 of the Regulations and clarifies importer related activities. In practice, your quality system is assessed as a whole rather than procedure by procedure, and your procedures must reflect actual practice, with evidence of use. GUI-0158, version 4.0 |
| 2 February 2026 | The FDA Quality Management System Regulation becomes the new content of 21 CFR Part 820 for medical devices, incorporating ISO 13485:2016 by reference. Vocabulary, records and documentary structure change. FDA, QMSR |
What is coming
| Date | What becomes required |
|---|---|
| 1 October to 31 December 2026 | Annual FDA registration renewal window, for drug and medical device establishments alike. A Canadian manufacturer exporting to the United States must complete it every year, with fees paid before registration can be completed. FDA, registration and listing |
| 14 December 2026 | New obligations for medical device establishment licences: documented procedures for distribution records, handling, storage, delivery, installation and servicing, corrective actions and incident reporting. The annual licence review must also carry your supplier information. SOR/2026-110 |
| 1 April 2027 | The deferred agile licensing provisions take effect: an acceptable risk management plan may become a condition of issuing a DIN, and may be required in a new drug submission where significant uncertainty or serious risk exists. It is also the annual deadline for your establishment licence review. SOR/2024-238 |
| 21 June 2028 | End of the transitional labelling exemption for natural health products. Every NHP must carry the modernized label: product facts table, minimum type size, contrast rules. Artwork and print lead times make this a 2027 file, not a 2028 one. SOR/2025-94 |
| 1 August 2028 | Fragrance allergen List 2 catches up with cosmetics already on the market. Health Canada, labelling of cosmetics |
| 31 May 2029 | Disinfectants holding a DIN must have obtained a market authorization as a biocide. The transition opened in May 2025 and goes largely unnoticed: it is the deadline most often missed by self care manufacturers. Sanitizers for food contact surfaces follow on 31 May 2031. Health Canada, biocides transition |
One date we do not display: cost recovery fees for natural health products still have no implementation date. Health Canada states that it will revisit the proposal and that final fees will be published in the Canada Gazette before implementation. If a supplier gives you a date, ask for the source.
The blind spot we see most often
A procedure that describes what you should do, rather than what you actually do, does not protect you. It exposes you further, because it documents the gap. It is the first finding we raise in audits, and the most expensive one to fix under inspection pressure.
What sets us apart, concretely
| The traditional consultancy | Us | |
|---|---|---|
| Price | On request, after several exchanges, billed hourly | Quoted at first contact, in writing, fixed at quote |
| Time to start | Weeks of queue before the first meeting | Scoping happens this week |
| Procedures | Written from scratch, billed by the hour | An existing library we adapt to your site |
| After the mandate | The binder stays, nobody knows how to maintain it | Handover and training of your team included |
| Time zone | Variable, often outside your hours | Quebec, in English and in French |
Our SOP library
We have assembled a dedicated platform of ready to use pharmaceutical policies and procedures, supervised by a pharmacist registered with the Ordre des pharmaciens du Québec. You buy the set, we adapt it to your site, and your teams keep it alive. That is what lets us hold prices that fully bespoke work cannot.
The first block online covers container content verification delegation and automation, including procedures for Parata MAX and other dispensing technologies, pharmacy technician training, certification and annexes 1 to 15, at a published price of 595 CAD. Further blocks join the catalogue as they are validated.
Three commitments you can check
Price before signature. You know what you pay before you commit. Per project for a one off dossier, annual retainer for ongoing support. Not one Canadian firm we surveyed publishes its rates. We give you ours at first contact, in writing.
A mandate that starts this week. No two month wait before the first scoping call.
Your time zone. We are in Quebec and we answer during your business hours, in English and in French.
How a mandate runs
| Step | What happens |
|---|---|
| 1. Scoping | A conversation to establish your product class, the applicable framework, the state of your documentation and the real deadline. No charge. |
| 2. Quote | A written scope, a price, a schedule. What is included and what is not, line by line. |
| 3. Execution | We produce, you approve. Every deliverable comes in a format you can maintain yourself. |
| 4. Handover | Training your team on what we put in place. A system nobody knows how to run does not survive its first inspection. |
| 5. Ongoing | On retainer: monitoring of rules that affect your products, maintenance of the documentation set, and inspection support. |
Questions we get
How long does a licence or a DIN take?
The timeline belongs to the authority and the product class, not to us. What we control is assembly time and the quality of the first submission. A complete dossier first time avoids the back and forth that is the real cause of long timelines.
Can you guarantee approval?
No, and be wary of anyone who promises it. The decision belongs to the authority. What we guarantee is a dossier that meets the requirements, built on schedule, and a company able to defend it.
We are not established in Canada. Can we still register?
Yes. Depending on the product class, a Canadian regulatory representative or importer of record may be required. We tell you exactly which role applies to your case, and we set up the arrangement before the filing, not after.
We already have procedures. Do we start over?
Rarely. The diagnostic exists precisely for that: keep what holds, correct what does not, and write only what is missing. Rewriting a full set when half of it is sound means billing you for work you do not need.
An inspection has been announced. Is it too late?
No. Inspection readiness is a mandate in its own right: documentation review, interview rehearsal, records and evidence put in order. Call us as soon as the date is known.
Do you work with small companies?
Yes. That is the whole point of the SOP library: giving a three person company access to a documentation set it could never afford to have written from scratch.
Are you our lawyers?
No. Our work is regulatory and technical. When a question is a legal one, we say so and we work alongside your counsel.
Let us talk about your file
Tell us what you need to register, or what your last inspection found. Scoping is free, without commitment, and you leave with a clear idea of the cost.
Cette page existe aussi en français: Affaires réglementaires, Santé Canada et FDA.