Formula & Monograph Assessment
Review medicinal and non-medicinal ingredients, doses, proposed claims, risk statements, and available evidence to identify a likely NPN application pathway and material gaps.
Scope this service →Regulatory infrastructure behind the Amazon offer
Get the product ready for the channel you intend to build.
Engage Nostrum for a standalone regulatory project or as part of an Amazon launch and operating scope. Every engagement starts with the product, evidence, sites, activities, and responsibilities, not a blanket bundle.
Discuss your regulatory scopeStandalone & scoped modules
Regulatory work with explicit boundaries
Modules can be combined after assessment. Deliverables, client inputs, third-party work, government fees, and ongoing obligations are confirmed in writing before work begins.
NPN Application Management
Prepare and manage Product Licence Applications, coordinate supporting evidence, submit agreed files, track correspondence, and support responses to Health Canada. Authorization and timing remain Health Canada decisions.
Scope this service →Site Licence Preparation & Renewal Support
Assess licensed activities and sites, prepare application or renewal materials, organize GMP evidence, and support deficiency responses. Scope is defined for the applicant and activities under review.
Scope this service →Bilingual Labelling & Product Facts Table (PFT)
Review English and French label content against the product licence and applicable NHP labelling rules, and prepare or review Product Facts Table content. Final artwork and claims are approved within the agreed review scope.
Scope this service →Quality Systems, SOPs, Records & CAPA
Develop or improve quality manuals, SOPs, specifications, training and distribution records, complaint and recall processes, deviations, change controls, and corrective and preventive action (CAPA) workflows.
Scope this service →Batch Documentation & QAP Release Support
Review batch records, specifications, certificates of analysis, testing, deviations, and supplier evidence for QAP disposition. A batch is released only when the complete evidence supports release; review does not guarantee acceptance.
Scope this service →Import Readiness
Map the Canadian importer, licensed sites, foreign-site evidence, product licences, labels, records, broker handoffs, and written responsibilities needed for an agreed import arrangement. Customs and regulator decisions remain outside Nostrum’s control.
Scope this service →Amendments & Ongoing Maintenance
Support post-licence amendments, notifications, renewals, label updates, evidence-file maintenance, quality records, and regulatory change planning through a defined ongoing scope.
Scope this service →How a scoped engagement works
1
Assess
We review the product, sites, activities, evidence, and intended Canadian operating model.
2
Define scope
A written proposal identifies deliverables, dependencies, responsibilities, exclusions, and commercial terms.
3
Prepare & review
We prepare the agreed work and identify evidence or decisions still required from you or third parties.
4
Submit or operate
Submissions, import activity, or batch release proceed only when their prerequisites are satisfied.
Bring us the current file, not a perfect file.
We will identify what is usable, what is missing, who owns each next step, and which services belong in scope.