Global Regulatory Intelligence for Regulatory Strategy and Good Practice

Authors: Sunil A*, Sanju A and Somya A

DOI: 10.23880/apct-16000113

Volume 1, Issue 3

Abstract

Bringing a new medical device or drug has become more challenging than ever in terms of competition, speed of delivery, regulatory monitoring, efficacy and safety and heavily depends on total quality management (TQM), globally. This is all about Good Regulatory Practice, as global regulatory requirements may vary from one country to another. Maximum regulatory compliance for a medical device can prove to be costly and regulatory intelligence would be required for the entire life cycle of the medical device as the regulatory strategy in terms of safety and efficacy. An effective regulatory policy leading to a competitive regulatory strategy is required.

Keywords: Medical device; Regulation; Regulatory intelligence (RI)

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