Our Quality Management System (QMS) is built around one goal: delivering products and services that our customers can rely on. By following established quality standards and documented procedures, we ensure that products and services meet customer expectations and requirements. This commitment to quality provides customers with confidence in the quality, consistency and reliability of every product we manufacture and a consistent experience from order through delivery.
ISO 13485
certified, GMP-compliant facility
50 yrs
manufacturing sterile-filtered fluids
95%
customer retention, year over year
Compliance, Consistency, and Confidence
Our ISO 13485:2016-certified quality management system supports every stage of the customer journey, from order processing through final shipment. For customers operating in highly regulated industries, our comprehensive documentation and quality practices provide the traceability, transparency, and confidence needed to meet demanding requirements.
Qualified Suppliers. Traceable Materials. Consistent Quality.
Quality starts before production begins. Raw materials are carefully qualified and sourced through approved suppliers, with each lot tracked from incoming materials through the finished product. This traceability provides clear documentation throughout the process, while formal change control ensures that updates to materials, suppliers, or manufacturing processes are reviewed and documented before implementation.
Reliable Processes. Consistent Results.
Long-term consistency is essential when you depend on a product to perform the same way from batch to batch. Once a formulation and manufacturing process are established, production follows documented specifications, qualified raw materials, and defined process controls to support repeatable results. When changes are necessary, they are carefully evaluated and implemented through appropriate engineering, qualification, or validation activities, with the supporting documentation required for your product and application.
Biologos Quality & Compliance-at-a-Glance
ISO 13485-certified, GMP-compliant manufacturing facility
Documented, lot-released production with a certificate of analysis on every lot
Sterility, bioburden, endotoxin, pH, conductivity, and osmolality testing per specification
Qualified raw materials and approved-supplier sourcing
Full lot traceability from incoming component to finished fluid
Formal change control, corrective and preventive action, and document control
Engineering, qualification, and validation batches to support change and implementation
50 years of manufacturing and a customer retention rate more than 95%
FAQS
Quality
Can your documentation support our regulated process?
The products we supply become part of your controlled process, and our documentation is prepared to support the diligence your product requires.
Do you provide a certificate of analysis?
Yes. We test every batch against its documented specification and release it with a certificate of analysis.
How do you ensure lot-to-lot consistency?
Established products are held to documented specifications, qualified materials, and defined manufacturing controls, with full lot traceability, ensuring the product you receive remains consistent over time.
How do you handle changes to a product or process?
Through formal change control, using engineering, qualification, or validation batches where appropriate, and with the documentation and communication needed to maintain continuity of supply.
How long have you been in business?
Fifty years, with a customer retention rate more than 95% — the clearest evidence that our quality holds.
Is your facility ISO 13485-certified and GMP-compliant?
Yes. We manufacture custom sterile-filtered buffers, media, reagents, and serum in an ISO 13485-certified, GMP-compliant facility.
What testing do you perform?
Depending on the product and your requirements, testing is customized to meet the customer’s needs; examples include sterility, bioburden, endotoxin, pH, conductivity, osmolality, identity, concentration, and appearance.