Life sciences industries are stepping ahead with new initiatives every day to align with the growing Regulatory restrictions put forth by the health authorities. But as the supervisory expectations of agencies are evolving at an increased pace, at times, organizations are finding it challenging to align with all of them on time.
December 6, 2018 Compliance, Audit and Validation
Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign.