FDA Premarket Approval (PMA) Testing: Requirements, Standards, and Labortory Support
Connecting with accredited labs worldwide ensures your device moves smoothly through the FDA PMA review process
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Swathi Kodaikal
Swathi Kodaikal, MSc, holds a master’s degree in biotechnology and has worked in places where actual science and research happen. Blending her love for writing with science, Swathi enjoys demystifying complex research findings for readers from all walks of life. On the days she's not writing, she learns and performs Kathak, sings, makes plans to travel, and obsesses over cleanliness.
Posts by the Author
Ultra-Trace PFAS Detection Explained: Tools, Standards, and Testing Labs
What contract labs need to know about ultra-trace PFAS detection methods, sampling control, and evolving compliance standards
Compounding Pharmacies and USP <797> Compliance
How contract labs support compounding pharmacies with sterility, potency, and compliance testing under USP <797>
NLEA Dietary Supplement Testing: Essential Compliance Services for Contract Laboratories
Here's how third-party labs verify supplement safety, potency, and label accuracy under US regulations
Manufacturing Maintenance, Repair, and Operations (MRO): A Critical Pillar of Reliability and Compliance
Explore how Maintenance, Repair, and Operations (MRO) supports compliance, safety, and reliability, and how labs enable testing and calibration
Biopharmaceutical Potency Testing: How Contract Labs Ensure Efficacy and Quality
Potency testing ensures biopharmaceuticals are safe and effective. Find out how contract labs deliver validated assays and global compliance
Third-Party Laboratory Insights for Consumer Product Testing
Practical guidance for ISO/IEC 17025–accredited labs supporting manufacturers, retailers, and brand owners in meeting safety, quality, and compliance requirements
Ask the Lab Expert: Building Resilient Contract Labs, Fostering Agility and Integrity
“Labs succeed when they build a collaborative and accountable culture...,” says Cheryl Bowden on fostering strong client relationships in the environmental testing industry
OECD 301 Biodegradability Testing: A Strategic Tool for Sustainable Product Development
OECD 301 testing determines the biodegradability of chemical substances, supporting regulatory compliance, environmental responsibility, and product innovation across global markets
Tackling FDA Import Detentions with Third-Party Lab Testing
How partnering with accredited contract labs can provide the critical testing and documentation needed to overcome FDA import detentions and get your products to market
TSE and BSE Testing Explained: Essential Methods and Compliance Standards
A round-up of advanced detection techniques and critical regulatory standards essential for industries using animal-derived materials
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