Every time a medication is taken, people inherently trust a complex system designed to ensure its safety and effectiveness. Behind the scenes, pharmaceutical companies face a constant challenge: navigating a maze of ever-changing global regulations. This is where Systech steps in. 

As a pioneer in pharmaceutical serialization and track and trace solutions with 40 years of experience, Systech provides cutting-edge solutions that help companies meet these stringent requirements and directly benefit the patient. By streamlining compliance,  pharmaceutical companies are able to market new, potentially life-saving treatments faster, giving quicker access to innovative therapies. Compliance ensures that the medications people rely on are genuine and haven’t been tampered with, providing peace of mind during treatment. 

Ultimately, we help pharmaceutical companies focus on what matters most: public health and well-being. By easing the burden of compliance, we empower them to dedicate more resources to developing new treatments and improving existing ones. 

The complex world of pharmaceutical regulations 

The pharmaceutical industry operates in a global landscape where regulations are stringent and vary widely from country to country. Each region has its own set of rules and requirements, which are constantly evolving. This creates a significant challenge for pharmaceutical companies that must continuously adapt to remain compliant. 

Let’s take a closer look at some of the critical regulations: 

• EU Falsified Medicines Directive (FMD): This directive aims to prevent counterfeit medicines from entering the EU market. It requires pharmaceutical companies to implement strict serialization and authentication measures to ensure the authenticity of their products. 

• US Drug Supply Chain Security Act (DSCSA): This act establishes requirements for tracing prescription drugs as they move through the U.S. supply chain. It mandates the implementation of systems to track and trace medications at the package level. 

• Serialization requirements in specific countries: Many countries, including China, Brazil and Turkey, have their own serialization requirements. These regulations often involve unique product identification codes and tracking systems. 

Navigating this complex regulatory landscape demands high organizational flexibility and technical expertise. Companies must be able to track their products in real time, document every step in the supply chain and ensure the accuracy and completeness of their data. This can be daunting, particularly in a digital world where information flows rapidly. 

Simplifying compliance 

Digital solutions are powerful tools for pharmaceutical companies in the face of these complex regulatory challenges. By leveraging technology, companies can optimize compliance and their operations, ultimately delivering safer medications to patients. 

Let’s delve into the key benefits of digitizing compliance: 

• Real-time track and trace: Imagine tracking a medication’s journey from the manufacturing plant to the pharmacy shelf. Digital solutions provide real-time visibility into the supply chain, allowing companies to identify and address potential issues quickly. 

• Automation: Manual processes are prone to errors. Automation reduces the risk of human mistakes by applying the compliance framework consistently. 

• Flexibility: Regulations are constantly changing. Digital solutions can be easily adapted to accommodate new or updated requirements, helping companies stay ahead of the curve. 

• Transparency: A clear view of the entire supply chain builds trust. Digital solutions offer a centralized platform for managing compliance data promoting transparency and accountability. 

By embracing digital compliance solutions, pharmaceutical companies can not only navigate the regulatory landscape more efficiently but also focus their efforts on developing and delivering the medications people need to live healthier lives. 

Your partner in compliance 

At Systech, we specialize in helping pharmaceutical companies navigate the complex world of global compliance. With four decades of experience, we understand your unique challenges and have developed cutting-edge solutions to empower you. 

Our UniTrace® L4/L5 platform is designed to simplify compliance while enhancing your operations. Here’s what sets it apart: 

• Comprehensive track and trace: Unparalleled visibility into your supply chain. From the moment a medication is manufactured to the point it reaches the patient, you can track its movement, ensuring authenticity and integrity. 

• Global compliance: UniTrace meets the requirements of major international standards, giving you the confidence to operate in any market. 

• Highly configurable: Your needs are unique. UniTrace is a flexible platform tailored to your requirements, ensuring a seamless fit with your existing systems and processes. 

• End-to-End traceability: A complete picture of your supply chain. This transparency helps you maintain compliance and fosters trust with your customers and partners. 

Systech is a full-stack provider—with offerings from Level 1 through Level 5. We deliver comprehensive solutions including serialization, line control and vision inspection—the foundation of supply chain traceability. Additionally, our UniSecure® product protection solution works with your existing package codes to identify counterfeits and detect diversion. 

We’re committed to helping you achieve your compliance goals while focusing on what truly matters: delivering safe and effective medications to patients worldwide. 

The Bottom Line 

Compliance is not just a regulatory hurdle; it’s a commitment to patient safety and trust. Systech’s innovative solutions empower companies to navigate the complex world of global regulations while focusing on what truly matters—developing and delivering life-changing medications. 

Ready to learn more about how Systech can help your company achieve its compliance goals and prioritize patient well-being? Explore our on-demand webinars and discover the power of digital solutions. Together, we can build a healthier future.