CAR T cell therapies have given rise to unprecedented enthusiasm, and hope among investigators, practitioners, and patients. The efficacy of CAR T cell therapy in
FDA Inspections are an integral part of the life science industry concerned with assuring products safety and efficacy. They are performed to highlight potential deficiencies
Pharmaceutical, biotech and medical device technology transfer involves transfer of knowledge in terms of processes, procedures and methodologies from site to site. Effective technology transfer
It is a guardrail for quality control, production integrity and good manufacturing practices (GMP) in the industry: the Quality System Record (QSR). In the ever-evolving
Here, we will discuss the best practices which any quality and regulatory consulting firm can provide to ensure a cross-functional tech transfer carried out seamlessly
These guidelines are intended to provide a detailed framework for the harmonization of stability data package required for the registration of Active Pharmaceutical Ingredients (APIs)
The Road to Successful Pharmaceutical Development: How the Right Consultant is Key to Innovation and Compliance in a Rapidly Moving Space. Pharmaceutical consulting is a
If you’re operating a clinical laboratory in the United States, obtaining a Clinical Laboratory Improvement Amendments (CLIA) certificate is essential for ensuring your lab meets
Supplier compliance, or the practice where suppliers must always maintain high levels of quality, safety and regulatory standards by manufacturers from the pharmaceutical and medical
Companies that provide consulting in quality and regulatory matter in the life science industry need to be aware of these recommendations, follow them up, and