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Regulatory launch playbook

How a regulated / pharma / fintech client in Poland executed a real end-to-end program — from RFQ to proof, production, QC and on-site delivery. Anonymised but representative figures for a program coordinated from the Warszawa hub.

When to use this playbook

The work covers the regulated / pharma / fintech sector in Poland with pan-European presence. Procurement is led by an internal category manager, with brand and marketing approval gates on artwork and Pantone matching Delta-E below 2.5. NDA signed before brief share; electronic invoicing via VAT 23% via KSeF. Use when launching a regulated product where every brand claim must be defensible against the approval dossier and the regulator could review the kit ex-post.

Step-by-step timeline

T-90: brief locked, claim list against the dossier locked, copy reviewed by Regulatory + Medical/Legal. T-60: artwork reviewed in Veeva Vault or equivalent, sign-off matrix complete. T-45: pre-production sample, last-mile copy check. T-30: bulk production. T-21: legal-hold release. T-7: distribution to verified channel only. T0: launch.

Outcomes and KPIs

Outcomes: zero regulator queries on kit content post-launch; HCP/recipient verified to 100% (signed channel list); legal-hold release filed in compliance dossier; ROI measured in regulatory-grade reach (verified HCP touches), not impressions. Cost per verified recipient EUR 25-75. Approval cycle compressed from a typical 4 weeks to 11 business days. Defect rate below 0.4% on inspected units. Payment Net 30/45 via SEPA after receipt; full VAT 23% via KSeF-compliant invoice issued on delivery day.

Pricing and lead times — Poland

All quotes in PLN excluding VAT 23%. Tier pricing on MOQ 50/100/250/500 units, with quantity breaks at 1,000+ and 5,000+. Standard lead times 7-10 business days from artwork sign-off, rush 4-6 days at +30-40%. Production coordinated from the Warszawa hub with DPD/InPost/DHL Express Poland nationwide; direct-to-office, direct-to-event and direct-to-home distribution supported.

FAQ

Can we see the actual brand name?

No — cases are anonymised under NDA. Named references after mutual NDA in the shortlist phase.

Are these real numbers?

Yes, anonymised but proportionally accurate (quantities, EUR ranges, lead times).

Can you replicate this for our company?

Yes — the same approach scales from 50 to 50,000 units, with price tiers documented upfront.

Do you handle electronic invoicing?

Yes — fully supported.

Who is the main point of contact?

A dedicated account manager at our hub, single email/phone for contract duration.

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