Nothing is constant in this world except change. That is why change must be answered with agility, mobility, and new ways of working.
In the Life Science industry, the rapid advances in genetics and immunology, combined with the technological revolution in laboratories and the hardening of the healthcare market, have created an environment where the perquisites for “success” are ever changing.
Through globalization, extended value creation chains, and the comprehensive, legally anchored monitoring of pharmaceutical products, the quality and integrability of a company’s business processes are now leading determinants of their potential.
At Zamann Pharma Support, we can assist pharmaceutical companies who want to benefit from these “new ways of working.” Our services include helping them hone and enhance their business processes, optimize their use of new technologies, and respond to growing needs with a customized corporate culture.
Serialization presents big challenges to pharmaceutical companies – and equally great opportunity. Indeed, every organization can boast of one common goal: ensuring that their medications are safely delivered to the
people who need them. To that point, the recent rise in counterfeiting, diversion, and other illicit activity has put that most important of missions in jeopardy.
This means that each unit you produce must now be identified via unique data, which, in turn, must be stored and accounted for over the course of years. Complying with these requirements presents new challenges that must be solved. These include managing the enormous volumes of data to integrating with CMOs, establishing connectivity with customers and trade partners for data exchange, and managing serialization in the warehouse just to name a few.
Most specifications for GxP compliance provide leeway for both discretion and customized implementation. At Zamann Pharma Support, we focus on identifying both the processes and all applicable regulations. We then develop customized solutions for the resulting tasks and integrate them into existing procedures. In doing so, we are careful to consider the company’s size, culture, and risk strategy so that we can guarantee the best possible result.
As a rule of thumb, we aim for maximum benefits from minimal effort. As your organization’s partner, we can quickly and reliably get to the heart of GxP Compliance. We are not only a strategically‐conceptual consultant, but are also here to offer practical support.