Quality & compliance
Quality and documentation
Each batch moves through a documented workflow from synthesis and purification to analysis and release. Records are assembled to align with EU research and pharmaceutical expectations.
Our quality framework
- GMP-aligned manufacturing
- Production runs at our GMP-aligned manufacturing site in Opole, Poland. Process conditions are controlled and defined per batch.
- ISO 9001-style quality system
- Operations run under an ISO 9001-style quality management system. Procedures, change control, and periodic review are documented.
- HPLC and LC-MS analysis, lot by lot
- Identity, purity, and release testing are performed in-house. Each lot is analyzed by HPLC and LC-MS before release.
- Certificate of Analysis
- Each batch ships with a Certificate of Analysis. It states identity and purity and carries a second-reviewer signature.
- Traceability and EU alignment
- Batch records and lot-level traceability follow each product from raw input to final vial. Supply is handled within the EU framework, including REACH obligations.
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What a Certificate of Analysis records
Every batch ships with a Certificate of Analysis. It states identity and purity for the specific lot, with the analyst result and a second-reviewer signature.
- Product name and, where applicable, the submitted sequence.
- Lot or batch number for traceability.
- HPLC purity result and the method used.
- LC-MS identity confirmation: observed mass against theoretical mass.
- Analyst result, second-reviewer signature, and date of analysis.
- Research-use-only statement.
Request a sample Certificate of Analysis
Ask the commercial team for an example CoA and a summary of the quality framework.
Manufacturing runs at our GMP-aligned Opole site under an ISO 9001-style quality system. Research-use-only products are supplied for laboratory research and are not intended for human or veterinary use.