Quality you can file
Every source is checked before we quote it, and every lot travels with the papers your regulator expects.
What travels with every lot
Your QA team should be able to approve a source from the file alone. We send it before you place the order, then again with the shipment.
How we hold quality
Five rules the trade desk works to on every order.
- 1
Registered sources only
We trade only from makers whose site and file we have checked. A new source is never introduced without your approval.
- 2
Good distribution practice
Storage, handling and transport follow GDP, so the material that arrives is the material that was released.
- 3
Traceable to the lot
Every pack carries the maker’s batch number, and every batch number leads back to its certificate.
- 4
Complaints answered in writing
A deviation or a complaint gets a written answer and, where needed, a corrective action agreed with the maker.
- 5
A trained team
The people who handle your order are trained in the documents and the regulations that apply to it.
Papers by product line
What we can send with a quotation. We confirm what each maker holds before you order.
Active ingredients
- Specification
- Recent certificate of analysis
- Safety data sheet
- Maker’s GMP certificate
- Open part of the DMF, or the CEP
Excipients
- Specification
- Recent certificate of analysis
- Safety data sheet
- Maker’s GMP or ISO certificate
- TSE, BSE and residual solvent statements
Finished products
- Certificate of analysis
- Certificate of pharmaceutical product
- Free sale certificate
- Maker’s GMP certificate
- Product file for registration
Packaging materials
- Technical data sheet
- Certificate of analysis
- Pharmaceutical contact compliance
- Maker’s ISO certificate