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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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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Join us and Thermo Fisher's Suja Sukumaran, PhD, to know how FTIR spectroscopy supports material identification, product testing, and regulatory compliance across industries
From stability testing and microbiological assessments to allergen and performance evaluations, these tests provide critical data for managing product quality and regulatory compliance.
Labs that invest in junior and mid-level staff build broader organizational competency, reducing dependence on specific individuals
With global supply chains expanding for repurposed anthelmintic APIs, robust third-party testing is essential to verify compound identity, ensure potency, and maintain strict regulatory compliance
Amazon opens its vast logistics infrastructure to all businesses. Explore its impact on contract testing operations, sample integrity, and laboratory sourcing
CS Analytical expands its New Jersey laboratory to enhance container closure integrity (CCI), raw materials, and gas qualification testing for the pharma and biotech industries
Ross Ashdown expands on some of the current challenges and future directions of lithium battery testing
The $1.075 billion sale of Thermo Fisher's antimicrobial susceptibility testing and culture media unit to private equity raises pressing questions about supply continuity, vendor relationships, and what comes next for the contract labs that depend on these products
Discover the critical laboratory tests hyperscalers and immersion fluid manufacturers use to certify dielectric coolants for AI data centers
How med-tech manufacturers are leveraging smarter material engineering and laboratory validation to hit sustainability targets without failing the FDA audit
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