FDA’s Nonclinical Testing Rule: What It Means for CROs Offering NAMs
US FDA's direct final rule rewrites drug and biologics regulations to cover in vitro, in silico, and organ-chip studies, giving NAM-ready CROs a clearer opening with sponsors
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Legal and Regulatory Articles
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Nationally Recognized Testing Laboratories (NRTLs): Their Role in Safety Compliance
An NRTL-certified product gets quicker market access, is known for consumer safety, and adds to the brand reputation
IEC Standards Testing: Ensuring Quality and Safety in Electrical and Electronic Products
The IEC standards continue to evolve, reflecting the dynamic nature of the industry and the ongoing commitment to excellence and safety
From Compliance to Capability: What 2025 Meant for Contract Labs
From PFAS to supply chain compliance, 2025 tested how contract laboratories really adapted
CLIA Certification: The Cornerstone of Quality and Compliance in Clinical Laboratory Testing
CLIA inspections and evaluations assess a laboratory’s performance, record-keeping practices, and quality assurance protocols
Regulatory Compliance and Requirements: The Technical Imperatives of Lithium-ion Battery Testing
Introduction: The Safety Gatekeeper for the Energy Revolution Lithium-ion (Li-ion) batteries...
Going Beyond Traditional Methods to Tackle Food Testing Demands
Here's how your laboratory can adapt to stay relevant in the evolving food safety and testing industry
How to Strengthen Chain of Custody in Third-Party Testing Labs
Unpack the critical processes that safeguard sample credibility—how to log, document, and audit custody in multi-industry contract labs
Compounding Pharmacies and USP <797> Compliance
How contract labs support compounding pharmacies with sterility, potency, and compliance testing under USP <797>
ISO Cleanroom Standards for Contamination Control
From air cleanliness classification to operational guidelines, these standards provide a comprehensive framework for ensuring that cleanrooms meet the necessary levels of cleanliness and contamination control.
The Unseen Link: Forensic & Identity Testing for Legal and Personal Answers
Explore the critical role of forensic and identity testing in providing irrefutable legal evidence and offering conclusive answers for personal matters
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