Quality
Quality systems and documentation
Our role as a downstream distributor is to ensure that every shipment leaving Catena Labs is accurately specified, fully documented, and traceable to its EU manufacturer. The standards below describe how we verify and document each lot.
Supplier qualification
We source exclusively from established European peptide and reagent manufacturers with documented quality management systems (ISO 9001 at minimum; GMP where the manufacturer's scope includes it). Each supplier is reviewed before onboarding using a standard qualification questionnaire covering quality system scope, analytical methods, deviation handling, and regulatory status. The questionnaire and supporting certificates are archived for audit.
Certificate of Analysis (CoA)
Each shipment is accompanied by a lot-specific Certificate of Analysis. CoAs include identity confirmation by HPLC and mass spectrometry, purity by HPLC area-% (typically ≥ 95% for research peptides; ≥ 98% for reference standards), water content where applicable, residual solvents where applicable, appearance, and counter-ion composition for salt forms. Methods and acceptance criteria are stated on every CoA.
Lot traceability
Every product is tracked by manufacturer lot number from receipt through to customer shipment. Inbound goods are inspected for label-to-CoA agreement, container integrity, and storage condition during transit. Outbound shipments reference the original manufacturer lot number on both the label and the shipping documentation.
Storage and shipping
Cold-chain products are stored and shipped according to the manufacturer's stated conditions, with temperature-controlled packaging and transit-time-aware coolant selection. Temperature excursions are recorded and assessed against product stability data before release.
SDS and CLP labelling
Safety Data Sheets are issued in accordance with Regulation (EC) No 1907/2006 (REACH, Annex II) and labels are prepared under Regulation (EC) No 1272/2008 (CLP). SDSs are available in English and Latvian; additional EU languages are supplied on request before shipment.
Complaints and deviations
Quality complaints are addressed to qa@catena.bio. Each complaint is logged, acknowledged within two business days, investigated against the relevant manufacturer's lot record, and closed with a written response. Trended complaint data informs supplier reviews.
Regulatory positioning
SIA Catena Labs operates as a downstream chemicals distributor under Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP). We do not manufacture, wholesale, or distribute medicinal products as defined under Directive 2001/83/EC. Products are supplied for laboratory research use only.