If you are sourcing pharmaceutical or chemical product from a new supplier, the risk you are pricing is not the product. It is the paperwork behind it.
A consignment held at your border costs you storage, a delayed launch, and sometimes the goods themselves. Everything below is aimed at predicting that risk before you commit to it — and each item is answerable in the first exchange, not the fifth.
1. GMP status, with a date
The first document to ask for is the GMP certificate — Good Manufacturing Practice, the standard confirming the plant operates under a documented quality system.
Three things matter, and "we are GMP certified" answers none of them:
- which authority issued it
- when it expires
- whether the manufacturing site named on it is the site that will make your product
Ask for the PDF. A supplier who has it to hand sends it the same day; a supplier who does not is telling you something useful.
2. Whether a CPP can be issued, and how quickly
The next question is not whether the supplier is permitted to export. It is how long a Certificate of Pharmaceutical Product takes to obtain — the document issued by the country of origin confirming the product is authorised there.
You need it to register, and you cannot sell before you register, so its lead time sits on your critical path rather than theirs.
A useful answer is a range: "usually X weeks for this product." An answer without a range is not something you can plan around.
3. Dossier completeness — stability data above all
If you are registering the product yourself, you need the technical file. Go to the stability data first.
The reason is practical: most of a dossier can be assembled in a few weeks, but stability data cannot be manufactured. It is the result of storing the product under controlled conditions over real time. If it is incomplete, your launch moves by months, and you want to know that before you negotiate rather than after.
Ask for the protocol and the time points completed to date. "Twelve-month data complete, twenty-four-month ongoing" is a plannable answer.
4. Capacity and minimum order, as numbers
A first shipment that goes well but cannot be repeated is worse for you than no shipment at all: you will have opened a market you then cannot supply.
Ask for two numbers — monthly capacity for that specific product, and minimum order quantity. Without them you are guessing, and the guess will be conservative.
5. Who will hold the marketing authorisation
This gets raised late and should be raised early. If you register the dossier, the authorisation is usually issued in your name — which gives you a position in that market, and gives the supplier a dependency they may not have thought through.
Both sides know it. Whoever raises it first looks professional rather than suspicious. Settle in writing, before the first proforma: whose name the authorisation carries, and what happens to it if the relationship ends.
6. How fast, and in what form, they answer
The sixth is not on any checklist and predicts more than the other five combined.
Throughout the exchange you are measuring one thing: when your consignment is held and a document is needed, how long until that document arrives? The only evidence available is how the supplier has answered you so far.
A team that replies within 24 hours with the file attached and a team that replies in a week with "we are following up" are two different risk profiles — and that difference is worth more than a few percent on unit price.
A first-email checklist
Everything above fits in one message:
| Ask for | Acceptable form |
|---|---|
| GMP certificate | PDF, expiry legible |
| CPP sample or issuing lead time | PDF, or a stated range in weeks |
| Dossier module list | One page, status per module |
| Stability data status | Time points complete and ongoing |
| Monthly capacity and MOQ | Numbers |
| Sample CoA | A real batch |
A supplier who can return that within two working days is a supplier who has shipped before. One who cannot may still be worth developing — but you now know the timeline you are actually buying.
Next step
If you are evaluating a specific supplier or looking for one that can meet these conditions, the assessment form asks what your market requires and where you are in the process. It takes about three minutes, and you get a written reply within two working days.