01.
What can ProPG source for a clinical trial?
Comparators and reference listed drugs, standard-of-care and co-medications, rescue medications, and clinical ancillaries.
We work to a protocol rather than to a catalogue. Send us the product, strength, presentation and quantity, together with the markets your study runs in, and we will come back with a realistic availability position — including where a product cannot be obtained. Scope is confirmed in writing before any commitment is made.
03.
What documentation is supplied with a delivery?
The documentation set is agreed at quotation, against your protocol and your quality function’s requirements. Depending on the product, the manufacturer and the source market, it may include a Certificate of Analysis for the supplied batch; a supply chain statement identifying the licensed source and market of release; batch number, expiry date and quantity reconciled to the delivery; temperature records where monitoring applies; commercial and customs documentation for the importing market; and a safety data sheet or TSE/BSE statement.
Document availability varies by manufacturer and by market, and manufacturers do not generally release batch manufacturing records into the distribution chain. We confirm in writing which documents will accompany a supply before you commit to it.
05.
Which activities does ProPG perform, and which are performed by qualified partners?
ProPG coordinates sourcing, licensed storage and distribution through licensed operations and logistics providers. It does not physically perform every activity itself.
Relabelling, secondary packaging and QP certification are carried out by qualified partners under contract at appropriately licensed sites, coordinated by ProPG as part of the supply.
We set the distinction out because it belongs in your supplier qualification file. A distributor is not a manufacturer, and a GDP authorisation is not a GMP authorisation. Which entity holds which authorisation is easier to establish at the start of a programme than during an audit.
02.
How do you establish provenance and keep supply within the authorised chain?
Product is sourced from manufacturers and from licensed wholesalers operating within the authorised supply chain in their own market.
For each supply we record the licensed entity the product was purchased from, the market it was released into, and the batch supplied. Storage and handling records are available for the applicable supply route, and include temperature data where monitoring applies. Records are available to your quality function on request.
Provenance is a documented record rather than an assurance. Where the chain cannot be documented to the standard your protocol requires, we say so at the availability stage rather than proceed.
04.
Can you supply from a single lot, and when do I receive batch and expiry details?
Single-lot supply may be achievable. It is established rather than assumed.
Whether a study can be supplied from one lot depends on the quantity required, the pack size, how the manufacturer releases stock into the market, and the length of your dosing period. We establish the position for your specific requirement before quoting, and we quote against a batch and expiry position obtained from the source rather than against a catalogue entry.
Where single-lot supply is achievable at your volume, we confirm it in writing. Where it is not, we set out what lot structure is achievable, so the decision sits with you before an order is placed. Batch, lot and shelf-life positions remain subject to stock availability until the order is secured.
06.
What do you need in order to quote?
Product name, strength and presentation; quantity, including your overage assumption; the market your protocol or registration requires the reference product to come from; delivery destination; required-by date; and any batch, expiry or documentation requirements set by your quality function.
A quotation reflects the latest source-confirmed position and is valid for the period stated on it. It does not reserve stock.
Send a comparator or RLD enquiry, and we will come back with a market and availability position first, and a quotation against a source-confirmed batch position second.