Laboratory-Developed Tests: Recent Regulatory Changes and Industry Effects
Evolving FDA regulations and legal rulings affecting LDTs have impacted clinical and contract labs—a recent development may change the course
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FDA
Audit Preparedness for Contract Labs and Testing Facilities: A Guide to Ensuring Compliance and Confidence
Proactive audit preparedness is pivotal to ensure third-party laboratories stay compliant, reliable, and competent in the TIC space
Vici Health Sciences Joins the Contract Laboratory Network!
This CDMO specializes in new chemical entity (NCE) molecule, NDA 505(b)(2), and ANDA development programs
Welcoming BioTools Inc., to the Contract Laboratory Network
Their product offerings include instrumentation, specialized CRO services, and unique software and accessories
Laboratory Quality and Compliance Week: FDA Warning Letter Trends for Testing Labs
Dr Constance Y. Fears, one of the speakers at our upcoming virtual event, discuses her career as a drug investigator and the FDA 483 Warning Letter trends
Welcoming Portrett Pharmaceuticals to the Contract Laboratory Network
This CRO delivers FDA ready, cGMP-compliant analytical solutions quickly to keep drug development programs on track
Welcoming Bioassay GmbH to the Contract Laboratory Network
They develop and perform GMP potency assays for a wide variety of drugs, proteins, monoclonal antibodies, vaccines and gene therapies
Environmental Microbiology in Water Testing: Everything You Need to Know
Environmental microbiology testing plays a critical role in assessing the safety and quality of water resources. Whether for drinking, industrial processes, agricultural irrigation, or recreational activities, water must be thoroughly monitored to ensure it is free...
FDA Clearance for First Automated Free Testosterone Test
FDA-Cleared Assay Advances Testing Efficiency and Accuracy
Laboratory Developed Tests (LDTs): An In-Depth Overview
The regulatory future of LDTs is evolving rapidly and the best way forward is to remain keyed-in
Gateway Analytical Joins the Contract Laboratory Network
Gateway Analytical specializes in process and formulation development, product-package validation, clinical & commercial manufacturing, visual inspection, quality control, and release testing
Ceutical Labs Is on the Contract Laboratory Network!
Ceutical Labs provides testing services for pharmaceuticals, cosmetics, and personal care products to support quality and compliance
Welcome CIA Labs to the Contract Laboratory Network!
CIA Labs, a full-service chemical analytical testing laboratory, provides comprehensive solutions for diverse industries
Food Allergy Testing: Importance, Types, and Methods
Diagnosing food allergies accurately is essential for effective management and prevention
Hydrogel Testing: A Laboratory Guide to Quality, Composition, Methods, and Regulations
Hydrogels have gained popularity due to their unique properties and applications in various fields, including medicine, agriculture, and personal care. This guide explores hydrogel testing, focusing on quality analysis, composition, testing methods, and regulatory requirements.
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ASK THE LAB EXPERT: How Azenta Is Bringing Automation and Sustainability to Ultra Low Freezers
Product Manager Cristiana Bercea expands on the current needs of ultra-low...
Implementing LIMS in Biotechnology and Life Sciences: A Comprehensive Guide
A modern Laboratory Information Management System (LIMS) can significantly...
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