FOR COMPANIES OUTSIDE CANADA
Is Canada worth it? Here's what to expect.
WHAT'S DIFFERENT HERE
Health Canada submission
New drug submission and review
Market authorization
Notice of Compliance (NOC)
HTA / reimbursement recommendation
CDA-AMC · INESSS
pCPA negotiation
With participating public plans
Jurisdictional agreements & listings
Each plan makes its own funding decision
Broader patient access
Public and private coverage
HTA / reimbursement review can begin before market authorization is received
Running in parallel
- Pricing and PMPRB requirements for patented medicines
- Canadian importer / Drug Establishment Licence arrangements
- Distribution and supply chain
- Patient support
- Pharmacovigilance / post-market responsibilities
- Medical and commercial launch readiness
An EMA or FDA dossier is not a Health Canada dossier, and access does not begin at approval. You don’t need to build a full Canadian affiliate to enter the market. Arctava can help establish and coordinate the local operating model around your market authorization — bringing together regulatory, market access, commercialization, importer and distribution partners, patient services, and other required Canadian capabilities.
Specialist quality, pharmacovigilance, distribution and field capabilities can be delivered through qualified partners within the operating model.
WHY ARCTAVA
Enter Canada without building a full Canadian affiliate
An alternative to an affiliate or out-licensing
You remain the Market Authorization Holder; we help establish and coordinate the Canadian operating model around your market authorization.
One accountable partner
Regulatory, access, commercial and operational workstreams coordinated by one team, with specialist quality, pharmacovigilance, distribution and field capabilities delivered through qualified partners.
Health Canada strategy and submissions
Regulatory strategy and pathway selection, NDS submissions, labeling negotiations and Canadian regulatory agent services.
A Market Entry Blueprint
Opportunity assessment, route to market and a 3–5 year P&L, in a business case that supports the investment decision.
Access planned from day one
Pricing, CDA-AMC and INESSS submissions and pCPA strategy planned alongside the regulatory filing, since reimbursement review can begin before approval.
Senior people, scaled to your needs
Leaders with 25+ years of senior commercial and general management experience in Canadian pharma, scaled up or down as your needs change.
WHICH SOUNDS LIKE YOU?