→ Regulatory Affairs
Filing IDs and submission identifiers
Identifiers that appear in regulatory submissions: establishment IDs, product identifiers, MAH references: flow from the master record into filings as part of the same event.
A product is only real in the systems that know its name
Product Codification is the unglamorous work of being known by the systems your product has to flow through: supply chains, reimbursement systems, regulatory ledgers, payer databases. Get it wrong and the product doesn't ship, doesn't reimburse, doesn't transact. Krevyos handles it as a property of the operation, not a spreadsheet maintained by hand.
- Domain owner
- Head of Master Data · Regulatory Operations · Supply Chain Identity
- Identifier types
- GTIN-14 · NDC · EU PCID · MAH · SPL · Reimbursement codes · Country identifiers
- Standards covered
- GS1 · FDA Listing (SPL) · EU EVMPD / IDMP · ATC / WHO · country-specific
Capabilities
GTIN-14 assignment per GS1 standards
GTIN-14 codes assigned and tracked against the products, packs, and presentations they identify with country-specific variants and re-issuance rules handled as part of the operation, so a packaging change surfaces the codification work it implies rather than running as a separate project.
- GTIN-14 assignment
- GS1 standards
MAH records and authorization linkage
Marketing Authorization Holder records held against the authorizations they reference so a MAH transfer or change is a tracked event with the implications for filings, labels, and pharmacovigilance already visible.
- MAH records
- Authorization linkage
NDC, EU PCID, and country identifiers
Country-specific product identifiers: NDC in the US, PCID in the EU, equivalents elsewhere: maintained as projections of the product master record rather than as separate datasets.
- NDC / EU PCID
- Country identifiers
SPL submissions and FDA Listing
FDA SPL submissions for product establishment registration and drug listing, generated from the product master record and submitted into the Establishment Registration & Drug Listing System, so a label or formulation change is reflected in SPL the same cycle rather than at the next quarterly review.
- SPL submissions
- FDA Listing
Reimbursement IDs and pricing codes
Country-specific reimbursement identifiers: payer codes, tender IDs, hospital pricing codes: held alongside the product they identify, so market access work isn't blocked on identifier hunts.
- Reimbursement IDs
- Pricing codes
Touchpoints
→ Market Access
Reimbursement and payer identifiers
Reimbursement codes, payer IDs, and tender identifiers feed market access work directly not as a one-off lookup project per market.
↔ Labeling
Pack-level identifiers on artwork
GTINs, country codes, and pack-level identifiers appear on artwork as projections of the master record not as values transcribed by hand.
← Organizations & Resources
Partner identifiers and establishment registration
Contract manufacturers and packagers carry their establishment identifiers as part of the partner record so SPL submissions and country registrations inherit the partner data structurally.
Outcomes
- 100%(indicative)
Identifier consistency across systems
Every system that consumes a product identifier reads it from the same master record: drift is a structural impossibility, not a periodic reconciliation.
Reimbursement holds caused by identifier mismatches
Identifier issues surface before submission rather than as a rejection from a payer.
- −80%(indicative)
Time spent on master data reconciliation
Reconciliation is replaced by single-source projection. The work becomes maintaining the master, not mediating between copies.
- +5×(indicative)
Identifier updates propagated per cycle
When an identifier changes, every downstream system sees the change as a property of the data not as a manual update task.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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