Resources

Guides for regulated logistics.

Plain, practical references on the regulations, corridors and cold-chain rules that govern how pharmaceutical and clinical material moves. Written by the team that builds the platform.

Need a quick definition? Browse the compliance glossary.

Compliance

How the regulations that govern pharmaceutical distribution work, and how to satisfy them in practice.

9 min read

21 CFR Part 11 in Logistics & Distribution

Part 11 is always explained for lab and QMS systems. Here is what it means the moment a shipment is approved, handed over or delivered.

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10 min read

Denied-Party Screening for Pharma

Sanctions lists are only half of it. Pharma distributors also have to screen for FDA debarment, DEA status and healthcare exclusion. Here is the full picture.

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7 min read

Annex 11 vs 21 CFR Part 11

Two rules, one goal, different emphases. Here is how EU Annex 11 and FDA Part 11 line up, and how to satisfy both with one system.

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8 min read

GDP Compliance Checklist

A working GDP checklist across the quality system, the Responsible Person, temperature control, transport and documentation.

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6 min read

IQ, OQ, PQ Explained

Installation, Operational and Performance Qualification, what each one proves, in plain language.

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7 min read

Temperature Excursion SOP and CAPA

A temperature excursion is a deviation. Here is the SOP from detection to disposition, and the CAPA that has to follow.

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7 min read

EAR vs ITAR Explained

Two US export-control regimes, very different consequences. Here is which one applies to life-science shipments and how to tell.

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9 min read

Controlled Substance Shipping Compliance

Controlled substances raise the bar on every part of a shipment. Here is what changes, from licensing to suspicious order monitoring to chain of custody.

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6 min read

Scitegrity and PharmaLogiks Compared

Scitegrity classifies the substance; PharmaLogiks moves the shipment. Here is where each fits, and why a controlled-substance operation needs both.

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Corridor guide

What each destination country requires to import pharmaceutical and clinical material.

8 min read

Importing Pharmaceuticals into Switzerland

Switzerland sits outside the EU customs union but recognises EU GMP. Here is what Swissmedic, Swiss customs and GDP actually require.

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8 min read

Importing Pharmaceuticals into Singapore

Singapore is the pharma gateway to Asia. Here is what HSA, Singapore Customs and GDP require to bring regulated material in.

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8 min read

Importing Pharmaceuticals into Germany

Germany is the largest pharma market in the EU. Here is how the AMG, QP release and the state authorities shape an import.

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8 min read

Importing Pharmaceuticals into the UK

Post-Brexit, Great Britain treats the EU as a third country for many imports. Here is what the MHRA, a WDA and QP oversight require.

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8 min read

Importing Pharmaceuticals into the United States

US drug imports are screened by the FDA at entry and, for investigational product, ride on an IND. Here is how it works.

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7 min read

UK Controlled Drug Import & Export

Controlled drugs in the UK need a Home Office licence and per-shipment authorities. Here is how the regime works.

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Cold chain

Temperature control, stability budgets and excursion handling for regulated shipments.

7 min read

Cold Chain Lane Qualification

A cold-chain lane is qualified, not assumed. Here is how packaging, ISTA 7D profiles and transit studies fit together.

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Clinical supply

Moving investigational product, IMP kits and biological samples for clinical trials.

8 min read

Shipping Clinical Trial Samples Internationally

Biological samples, cold chain, customs and dangerous goods, all at once. Here is the practical sequence for shipping trial samples across borders.

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8 min read

IMP Kit Reconciliation & Accountability

Every investigational kit has to be accounted for, from receipt to destruction. Here is how IMP reconciliation and drug accountability actually work.

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Operations

The day-to-day mechanics of shipping regulated material across borders.

7 min read

HS Codes & Customs Docs for Pharma

The HS code and the invoice are where most pharmaceutical customs holds start. Here is how to get them right.

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6 min read

Dry Ice and UN3373 Shipping

Dry ice and biological substances are dangerous goods. Here is what UN1845 and UN3373 actually require.

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See it live in 25 minutes.

Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.

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