Market opportunities include providing training for analytical method validation, offering services for the transfer and verification of analytical procedures, developing compendial coordination ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...

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 ...

In a case relating to use of recombinant human interferon-β (IFN-β) proteins for the treatment of viral diseases, the US Court of Appeals for the Federal Circuit ruled that a “product-by-process” ...

This article evaluates bulk analysis and scratch analysis methods for particle dispersion, highlighting the superiority of ...