On March 18th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro ...

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

According to BCC Research, increasing regulatory requirements and the need for data accuracy are driving demand for ...

Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...