CONTROL / 01Nostrum-delivered within scope
QAP & documentation
Quality procedures, specifications, forms, supplier and product records, and change-control expectations are defined for the agreed operation.
Quality & Canadian operations
Control the handoffs between approval and saleable inventory.
Nostrum structures the quality, import, release, receipt, and record workflows required by the agreed Canadian operating model—while keeping warehouses, carriers, laboratories, manufacturers, and the client visibly accountable for their work.
Licensed-scope note
Nostrum Health Inc. maintains NHP Site Licence 303151. Each product, activity, site, foreign-site evidence package, and import arrangement must be assessed for applicability before work begins.
Operating control map
Every recurring control needs an owner and evidence.
These capabilities are modular. The engagement schedule identifies which controls Nostrum performs, which it coordinates, and which remain with the client or a qualified third party.
CONTROL / 02Nostrum-delivered within scope
Batch Release
Required production, testing, packaging, and traceability records are reviewed against the applicable specification before a documented disposition.
CONTROL / 03Nostrum-delivered + coordinated
Import arrangement
Importer responsibilities, shipment records, product and site eligibility, and border/logistics handoffs are mapped before shipment.
CONTROL / 04Nostrum coordinates with warehouse
Receipt & exceptions
Inbound identity, quantities, lot details, condition, and exceptions are captured through the agreed receipt workflow.
CONTROL / 05Third-party warehouse
Warehousing
Storage, status control, inventory segregation, and environmental requirements are assigned to an assessed warehouse arrangement.
CONTROL / 06Third-party provider + coordinated
Fulfilment
Approved inventory can move through agreed direct, retail, or marketplace fulfilment workflows with lot-level records where required.
CONTROL / 07Shared, explicitly assigned
Records & traceability
Distribution, complaint, investigation, and disposition records are retained according to the documented responsibility map.
CONTROL / 08Shared; decision rights defined
Recalls & returns
Escalation, quarantine, investigation, notification, reconciliation, and disposition steps are documented before an event occurs.
Five operating gates
Product moves only when the next gate has what it needs.
- GATE / 01
Product & licence fit
Confirm the product authorization, licensed parties, sites, specifications, and proposed Canadian arrangement.
- GATE / 02
Quality readiness
Identify missing records, testing, agreements, labels, or procedures before product movement.
- GATE / 03
Shipment readiness
Confirm the approved scope, batch documentation, shipment data, and logistics handoffs.
- GATE / 04
Release & distribution
Document disposition, status, receipt, storage, and distribution records before saleable inventory moves.
- GATE / 05
Ongoing control
Maintain complaint, return, recall, change, deviation, and traceability workflows for the agreed operation.
Boundary conditions
Coordination is not the same as performing every activity.
Nostrum’s role
Perform the quality and regulatory tasks expressly listed in the engagement; maintain the agreed documentation and escalation cadence.
Client’s role
Provide complete, accurate, and timely product, licence, manufacturing, testing, shipment, sales, complaint, and distribution information; retain defined decision rights.
Specialist providers
Manufacturers, laboratories, customs professionals, carriers, warehouses, fulfilment providers, and platforms perform their contracted services and remain responsible for them.
Regulatory outcomes
Health Canada, border agencies, marketplaces, and other authorities or platforms make their own decisions. Timelines, acceptance, clearance, and commercial outcomes are not guaranteed.
Start before inventory moves