ISO 13485 is international standard which defines the requirements for a quality management system (QMS) in medical devices organization. The pursuit of an ISO 13485
One critical necessity looms large throughout the myriad labyrinth of regulations which dictate the world of life sciences: Internal audits. Pharmaceuticals, biotech and medical devices
Each time we go to pick up a bottle of pills, we are putting an enormous amount of faith in the medical world, assuming whatever
Adapted from an article first published by the world’s leading life science innovation knowledge hub. With mRNA Immunotherapies are breakthroughs in life science industry. With
Stay informed about the recent regulatory changes that impact the life science industry. The US Food and Drug Administration (FDA) oversees this space, adjusting its
Introduction to Stability Testing Regulations demand robust usability of stability studies as an integral component of drug development and manufacturing process. Stability Studies are an
Quality standards and regulations that contribute to the safe, efficacious production of finished pharmaceuticals rely on a robust framework set forth in myriad guidelines and
The objective of 21 CFR Sec. 211.184 intends to follow in its second dual purpose of advocating for strong quality control systems and advancing the
In August 2020, the Food and Drug Administration (FDA) announced a draft guidance for industry titled Cellular & Gene Therapy. The guidance is intended to
In the Medical device and Life sciences industries, obtaining Investigational Device Exemption (IDE) approval is a critical step for initiating clinical studies. Successful IDE applications require precise documentation, compliance with FDA regulations,