Clinical trial comparators and reference drugs
Sponsors and CROs need comparators from a traceable source, often from one batch, with long remaining shelf life and full documentation. We source them from manufacturers and authorised distributors and supply them with their pedigree.
In short
Comparator sourcing is the procurement of marketed medicines used as the reference arm, standard of care or rescue medication in a clinical trial. MedsAcross sources comparators and reference listed drugs from licensed manufacturers and authorised distributors, with batch, expiry, certificate of analysis and chain-of-custody documents for every lot it supplies.
What it is
A trial may need the innovator product, an approved generic, a presentation from a specific market or a large quantity from a single batch. Sponsors also ask for ancillary medicines such as premedication or rescue therapy.
We quote per lot with the batch number, expiry date and remaining shelf life, and we hold the batch once you confirm. Every shipment travels with the documents your QA team needs to release it.
Who it is for
- Sponsors running multinational trials
- CROs managing comparator supply for sponsors
- Clinical supply, packaging and depot companies
- Bioequivalence centres needing reference listed drugs
Who uses this service
How it works, step by step
Typical times from our process. Your quote shows the lead time for your medicine and your country.
- 1
Requirement
Same dayShare the product, strength, pack, quantity, market of origin, minimum shelf life and protocol reference.
- 2
Company verification
1 business dayWe verify your organisation and screen it against sanctions lists.
- 3
Lot proposal
24 to 48 hoursWe confirm availability with batch, expiry and the documents each source can provide.
- 4
Quote and reservation
On acceptanceA quote per lot with validity and lead time. The batch is reserved once you accept.
- 5
Export clearance
Up to 7 working daysWhere the product needs an export NOC from India, the manufacturer's NOC is issued within 7 working days under the current process.
- 6
Dispatch to depot or site
3 to 15 days transitShipped in the right temperature lane with the logger file and the full document pack.
Documents needed
Your quote comes with a checklist that shows who provides each document and its status.
Certificate of analysis
For each batch, from the manufacturer.
Pedigree and chain of custody
Traceability from the manufacturer to us and on to your depot or site.
Manufacturing licence and GMP certificate
For the site that made the batch.
Temperature records
Storage data for the lot and the shipment logger file.
Commercial invoice and packing list
With batch, expiry and quantities per carton.
Export NOC
Where the product needs one, with details that match the shipping bill.
Legal route notes
Rules differ by country and change over time. Each note cites a regulator or a published legal analysis. Your local regulatory adviser confirms the route for your case.
Comparator buyers expect a certificate of analysis, stability data and full comparator documentation for the lots they receive.
Source: Pharmaceutical Technology, comparator sourcing case study
Under CDSCO's export NOC 2.0 process, manufacturer NOCs are issued in 7 working days and stay valid for one year. Unexported stock below 60% residual shelf life must be destroyed.
Source: Lexplosion, CDSCO export NOC 2.0
A 2026 public notice of the Jawaharlal Nehru Custom House says that after 30 September 2026 export clearance of unapproved, new and banned drugs is strictly subject to the CDSCO order, and shipping bill details must match the NOC.
Source: Jawaharlal Nehru Custom House, public notice 88/2026
Since 30 April 2024, export NOCs for unapproved, new and banned drugs are issued by CDSCO rather than state authorities.
Source: USISPF, CDSCO NOC for unapproved, banned and new drugs for export
Check your country
Each import guide lists the regulator, the legal routes, the documents and typical approval times.
Questions and answers
Can you supply a single batch for the whole trial?
Often, yes, when the manufacturer or distributor holds enough stock. We confirm the quantity per batch before you accept and reserve it once you do.
What remaining shelf life can you offer?
It depends on the batch available. Each lot proposal shows the expiry date, so your team can check it against the treatment period before accepting.
Do you relabel or pack comparators into kits?
No. We supply comparators in their original packs with their documents. Blinding, relabelling and kit packaging stay with your clinical packaging partner, and we can ship straight to them.
Can you ship to several depots?
Yes. Each consignment gets its own documents and temperature lane, and the quote lists the Incoterm and lead time for each destination.
Request comparator availability
Send the product list with quantities, minimum shelf life and the destination depots.