PSC Biotech

Our customers in the life sciences industry face the critical challenge of bringing life-saving products to market safely, efficiently, and in compliance with ever-evolving global regulations. At PSC Biotech, we understand that navigating the complex landscape of regulatory requirements, quality assurance, and operational excellence is not just a box-checking exercise but a vital component of public health and patient safety. That is why we have dedicated over two decades to becoming a strategic partner that empowers pharmaceutical, biotechnology, and medical device companies to achieve their goals with confidence.

We provide a comprehensive suite of professional services and innovative software solutions designed to streamline your operations and ensure compliance at every stage of the product lifecycle. From Commissioning, Qualification, and Validation (CQV) to Computer System Validation (CSV) and Auditing, our global team of experts—including former FDA auditors—brings unparalleled local insight and worldwide expertise to your projects. By integrating our cutting-edge cloud-based software, such as the Adaptive Compliance Engine (ACE) and AuditUtopia, we help you modernize your quality management systems, reduce risk, and accelerate your time to market, allowing you to focus on what matters most: improving human health.