Effective Strategies to Ensure Your Quality Management System Meets FDA and ISO Compliance
Blog Ensuring Your Quality Management System Meets FDA and ISO Compliance Are you concerned that your quality management system is not fully compliant with the standards set by the Food and Drug Administration? Do you want to make sure your quality management system is on par with global standards? To make sure that your organization […]
Quality Assurance and Quality Control for Biotech Industries
Blog Quality Assurance and Quality Control Did you know that the global biotech industry is expected to be worth more than $3 trillion by 2030? With a number like that, it isn’t surprising that biotechnology is gathering so much attention. With the ability to affect most areas of our lives, this could soon be the most […]
CDISC SEND Controlled Terminology Best Practices
CDISC SEND Controlled Terminology Best Practices Are “Not Done” and “NOT DONE” the same? Not in CDISC SEND controlled terminology. The correct use of controlled terminology is a critical part of submitting study data to the FDA. It can be challenging, though. A PDF of the current CDISC SEND controlled terminology has several pages. It […]
Best Practices for Enabling FDA SEND Compliance
Best Practices for Enabling FDA SEND Compliance What is FDA SEND Compliance? The Clinical Data Interchange Standards Consortium (CDISC) created the standard. FDA SEND supports the approval process. SEND stands for the Standard for Exchange of Non-clinical Data. It’s vital to follow FDA SEND compliance regulation guidelines to streamline the approval process. The Study Data […]
A Guide on FDA Study Data Submission Requirements
A Guide on FDA Study Data Submission Requirements The Challenges in Complying with SEND The evolving guidance of the FDA on nonclinical dataset submissions requires organizations to adapt procedures to ensure full regulatory compliance. The Food and Drug Administration rejects as many as one in three study data submissions due to technical factors. Nonclinical studies […]
