The process at a glance

Product classification sheet

What is this product's control status in the country of origin and in the destination?

What the document contains

• Product identity: generic name or INN, dosage form, strength, HS code
• Control status in the country of origin, with the governing rule cited
• Status against international control lists and pharmaceutical schedules
• Status in the destination country and the authority that decides it
• Date of assessment, sources cited, and who carried it out

When it is produced

Before pricing and before any correspondence with a buyer. Produced once per product and kept in the product file.

Illustrative sample — no client information is used.

Regulatory assessment and registration path

To sell this product in this market, which documents are needed, in what order, and over what timeline?

What the document contains

• The approving authority in the destination market and the legal route that applies
• The document list, separating prerequisites from documents that depend on them
• Sequence: what has to be obtained before what
• Time estimate per stage, given as a range with the reasons it moves
• Identified risks and the points where a dossier typically stalls

When it is produced

At the start of an engagement, once the target market is chosen and the product classification is settled.

Illustrative sample — no client information is used.

Counterparty and market screening report

Is this buyer real, and does this market make sense for this product?

What the document contains

• The buyer's legal identity: registration number, address, year established
• Sanctions and control-list checks, naming each list and the date checked
• Stated end user and end use, and whether they are consistent with the volume requested
• The counterparty's import licence or distribution authorisation status
• Market picture: competition, entry requirements, and known barriers
• Conclusion: proceed, proceed with conditions, or stop — with the reasoning written down

When it is produced

Before a proforma invoice is issued, and again if the end user or order volume changes.

Illustrative sample — no client information is used.

Pre-shipment compliance checklist

Is this shipment ready to be booked?

What the document contains

• Product technical documents: the required licences, certificate of analysis, GMP
• Destination regulatory documents: valid registration, CPP, approvals from the relevant authorities
• Commercial documents: invoice, packing list, certificate of origin, bill of lading, insurance, and the relevant permits
• Labelling and packaging against the destination country's requirements
• Transport and storage conditions, including cold-chain requirements where they apply

Illustrative sample — no client information is used.