Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring the highest ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Clinical Laboratory Improvement Amendments, or CLIA, are a high bar as set by the US Government under Clinical Laboratory Improvement Amendment 42 CFR 493.1253 to obtain and maintain quality ...

Animal testing is often used to evaluate the potential risks, uses, and environmental impacts of chemicals. New Approach Methodologies (NAMs) are technologies and approaches that can potentially ...