Cost + timeline for a compliant pharma Magento build?

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Realistic ranges. These are not normal e-commerce numbers:

Magento + Hyvä storefront + checkout + B2B: $50k, $150k. Same as a regulated-industry build any other vertical.
Compliance modules (Rx validation flow / pharmacist queue / DEA-CSOS / state-restriction engine / Part-11 audit trail / e-signatures): +$80k, $200k. This is the work that doesn’t exist on any other vertical.
Cold-chain integration (per-SKU routing + temp-logger + excursion handling + 2-4 carrier APIs): +$25k, $60k.
Serialization integration (TraceLink / rfxcel / SAP ATTP / Tag-It bridge + AS2 / EPCIS): +$40k, $120k. Add $10k, $25k per trading partner onboarded.
Validation pack (IQ / OQ / PQ docs, test scripts, change-control process, SOPs): +$20k, $80k. More if your QA team wants formal CSV (Computer Systems Validation).
Regulatory pre-audit (external GDP / GxP auditor before live release): +$15k, $50k.

Total typical scope: $230k, $660k. Yes, that is what regulated pharma e-commerce costs. Anyone quoting <$100k for a fully compliant pharma Magento build is missing scope or skipping validation. Anyone quoting >$1M is probably gold-plating or selling enterprise SaaS overhead.

Timeline: 6-12 months end-to-end. Phasing helps: Phase 1 (4 months) ships storefront + Rx flow + B2B + 1 compliance region. Phase 2 (3 months) adds cold-chain + serialization. Phase 3 (3 months) adds 2nd / 3rd region + audit pack. Don’t skip phasing, one big-bang regulated-software launch is how teams get themselves a 483 letter.

Ongoing: $5k, $15k/mo for through-quarter compliance + regulatory updates + middleware connection fees + GDP-audited carrier costs (these are a pass-through, but you administer them). Add $30k, $200k/yr if you’re on Adobe Commerce instead of Open Source.

Cheaper alternative path: start on a specialty platform (Truepill / NowRx) + add Magento later for B2B + multi-region. Two-platform reality is harder to operate but cuts time-to-launch in half and de-risks the regulatory-affairs ramp. I’ve recommended this to two clients in the last 18 months, both shipped faster + at lower total cost than a single-platform Magento build would have allowed.