What We Offer
Our services range from short to long term laboratory start-up in addition to validating complex samples types with guidance on endotoxin masking in biologics commonly referred to low endotoxin recovery (LER). Our expertise lies with knowledge of all reagents, hardware and software technologies provided by all LAL/rFC manufacturers. We offer guidance and focus on new technologies to validate first time right with intense focus on data integrity.
Laboratory Start-Up
Expertise on best methods, hardware, software and LAL/rFC Reagents needed. We recognize the need for low sensitivities/sample treatments to overcome potential interference.
On-Site Training & Troubleshooting
We offer short and long term on-site assistance with full training classes with certification. Our goal is make offer peace of mind once a process has been validated with full support a continual basis.
Validation & Documentation
We offer guidance on development of standard operating procedures on all aspects of the endotoxin test specifically with your sample in mind.
FDA Mock Audits and Representation
We off full support during a FDA audit and will also perfom mock audits specifically on your endotoxin testing process to ensure all processes are providing accurate data. Meta-Data is examined under scrutiny.