Documentation
Every document, what it proves, and how long it takes
Buyers ask for documents by name without always knowing what each one demonstrates. Asking for the wrong certificate is the fastest way to lose three weeks on a first order.
The library
| Document | Supplied | Lead time | Issued by | What it proves |
|---|---|---|---|---|
| Commercial invoice | Standard | Same day | Us | The commercial terms of the sale: goods, quantities, values, Incoterm, HS codes. Customs values duty from this document, so the HS code has to match the description. |
| Packing list | Standard | Same day | Us | Carton by carton contents with batch numbers, expiry dates, gross and net weights and dimensions. This is what an inspector checks against the physical consignment. |
| Certificate of Analysis | Standard | With the batch | Manufacturer | Test results for a specific batch against the finished product specification. Batch-specific, not a generic product sheet. If a supplier sends the same CoA for two batches, something is wrong. |
| Certificate of Origin | Standard | 2 to 3 days | Chamber of Commerce | That the goods were manufactured in India. Needed for preferential duty under trade agreements and required outright by several markets. |
| Safety Data Sheet | On request | 1 to 2 days | Manufacturer | Hazard classification, handling, storage, first aid and transport information in GHS format. Freight forwarders increasingly ask for it before accepting a booking. |
| GMP certificate | On request | 2 to 5 days | State FDA | That the manufacturing site complies with Good Manufacturing Practice for the listed dosage forms. Site-specific and form-specific. |
| Certificate of Pharmaceutical Product | On request | 2 to 3 weeks | State FDA or CDSCO | WHO-format confirmation that the product is licensed in India and made at a GMP-compliant site. The document most registration authorities will not proceed without, and the slowest to obtain. |
| Free Sale Certificate | On request | 1 to 2 weeks | State FDA | That the product is freely sold in India. Often accepted in place of a CoPP for feed supplements and non-medicinal lines. |
| Stability data | On request | 3 to 7 days | Manufacturer | Accelerated and long-term stability supporting the shelf life, in a stated climatic zone. Zone IVb data is standard from Indian plants. Zone II data for Europe is not always available. |
| Method of analysis | On request | 3 to 7 days | Manufacturer | The analytical methods behind the specification. Required for most registration dossiers and sometimes for a destination laboratory to verify a batch. |
| Veterinary health certificate | Market dependent | 1 to 2 weeks | Government authority | Required for biologicals and some animal-origin products. The format is usually dictated by the importing country, so send us their template. |
| Import permit reference | Market dependent | You obtain it | Your authority | Several markets require a permit per consignment, not per product. It has to exist before the goods ship, and copying us on it avoids a customs hold. |
The order to request them in
Start the Certificate of Pharmaceutical Product first, because it is the slowest and everything else can catch up with it. Then the GMP certificate and Free Sale Certificate, which run in parallel. Stability data and method of analysis come from the manufacturer directly and are usually quick. The shipping documents are generated at dispatch and are never the bottleneck.
If your authority requires legalisation, tell us at quotation stage. It is the difference between a six-week lead time and a twelve-week one, and it is entirely predictable.
Common questions
Which documents come as standard with every shipment?
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Commercial invoice, packing list, batch-specific Certificate of Analysis and Certificate of Origin. Everything else is on request, and most of it is free. The exceptions are documents requiring legalisation or apostille, which we charge at cost.
How long does legalisation add?
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Typically two weeks on top of the document itself. Attestation by the Indian Ministry of External Affairs, then by your embassy in New Delhi. Some Gulf markets also require a chamber of commerce attestation in between. Budget four to six weeks total if your authority wants a legalised CoPP.
Can I get sample documents before ordering?
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Yes. We send redacted examples of a Certificate of Analysis, a commercial invoice and a packing list so your customs broker and regulatory consultant can confirm the format works for them before any money moves.