Pharmaceutical supply chains are a complex global network with a multitude of stakeholders including contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), contract packaging organizations (CPOs), logistics providers, wholesalers, dispensers and regulators. Ensuring the integrity, safety and availability of medicines is becoming more challenging. With growing regulatory demands and the necessity for accurate, real-time product traceability—the need becomes even more pressing. 

As vital external partners in the pharmaceutical manufacturing space, CDMOs, CMOs and CPOs are focused on maintaining regulatory compliance, keeping lines up and running and accelerating time-to-market for their client’s products. Their success hinges on upholding the highest quality standards while remaining agile in the face of evolving regulatory and operational demands.

To meet these demands, the entire industry continues its digital transformation. Today’s pharmaceutical leaders are embracing technologies such as artificial intelligence (AI), machine learning (ML) and radio-frequency identification (RFID) to enhance real-time oversight, improve compliance, enhance product safety and create more resilient supply chains.

Challenges in pharma supply chains

Pharmaceutical supply chains have long faced fragmentation. With operations often spread across regions and involving multiple partners, from CMOs to third-party logistics providers (3PLs), maintaining oversight is inherently difficult. Add variables like geopolitical uncertainty and increasing demand from consumers and patients for greater transparency, and the risks to continuity and compliance become clear.

Regulatory pressures also continue to grow. The EU Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA), have raised the bar for documentation and traceability, pushing manufacturers to adopt serialization and verification systems that ensure products are legitimate and safe. However, while regulatory compliance has improved supply chain security in these regions, gaps in real-time visibility still exist. 

Moreover, data remains siloed across supply chain stakeholders. Even with regulations in place that require standardized, interoperable systems for sharing data, once a product enters the supply chain there are many unknowns. Companies need to embrace new technologies and manage the change with training to enhance seamless data exchange, minimize disruptions and keep product moving. Addressing this disconnect is critical not only for regulatory compliance but for strengthening patient safety and operational efficiency.

Digital technologies driving supply chain transparency

The industry is now witnessing a shift from traditional compliance-focused approaches to more holistic digital ecosystems. At the center of this shift is the rise of connected packaging—data-driven technologies that extend traceability, improve authenticity and enable supply chain visibility from production to the patient.

Connected packaging solutions such as RFID, near field communication (NFC) and QR codes enable manufacturers and their partners to track products in real time, monitor temperature conditions and detect unauthorized handling or diversion. This is especially vital for biologics, vaccines and other sensitive therapies.

The proliferation of illicit online pharmacies has further elevated the importance of product verification. Investigations have uncovered fraudulent digital pharmacies targeting vulnerable patients during shortages, placing even more urgency on companies to authenticate their products and maintain end-to-end visibility.

The adoption of digital and smart packaging is undoubtedly accelerating across the industry. As brand owners and pharmaceutical companies enhance their packaging with these technologies to drive patient engagement and combat counterfeiting, contract packagers must be prepared to support these evolving requirements. This includes integrating the infrastructure, processes and expertise needed to implement these technologies effectively across diverse packaging lines.

Enhancing compliance and safety

It’s evident that technologies like serialization and track and trace, which were implemented over the past decade, form the backbone of compliance strategies. However, when combined with AI and ML, they evolve into active, intelligent systems capable of flagging risks and informing real-time decisions.

Today, the integration of AI and automation is becoming a critical enabler for modern pharmaceutical packaging operations. AI-driven quality inspections help reduce manual errors and ensure consistent, high-quality output, while robotic automation delivers faster, more efficient packaging line performance. These technologies not only improve operational agility but also support the ability to comply with increasingly stringent regulatory standards.

AI/ML at the line level and beyond

AI and ML can make a tangible impact on the packaging line in a variety of ways. Smart cameras can be used to perform print quality inspections—for static data, such as logos, as well as variable data—and to detect other anomalies. They can also augment the line inspection process during batch change overs. Leveraging AI technology to automate manual processes can help reduce errors and waste while enhancing overall efficiency. These are just some examples of how intelligent vision systems can improve productivity.

Beyond the packaging line, AI and ML are increasingly used to drive predictive analytics, giving manufacturers critical insights to forecast inventory, anticipate product shortages and quickly detect exceptions such as counterfeiting and diversion. These technologies are essential for building agile, responsive supply chains.

Seamless data exchange

Another barrier to supply chain transparency is inconsistent or incomplete data exchange between trading partners. The industry is turning to platforms that provide an integrated, end-to-end solution that allows pharmaceutical manufacturers to capture, analyze and share data across the entire supply chain.

By embedding detailed product data into unique codes, companies can facilitate downstream access to critical information, from production dates and batch numbers to environmental history and intended destination. 

Furthermore, blending additive technologies with non-additive methods allows companies to build layered defenses into existing packaging infrastructure. This interoperability enables widespread adoption without the need for expensive overhauls.

As the pharmaceutical landscape continues to evolve, the next frontier in supply chain innovation will be autonomous, data-driven operations fueled by AI, ML and connected technologies. Regulators are increasingly signaling a preference for real-time data exchange and automation to address delays and enhance patient safety.

What’s now and what’s next 

The pharmaceutical industry stands at a pivotal moment. Faced with increasing complexity, regulatory pressure and risks like counterfeiting and supply chain disruptions, companies must embrace advanced technologies not just for compliance, but to build smarter, more resilient operations.

Digital solutions like AI and connected packaging are no longer optional—they are essential. They enable real-time visibility, secure data exchange, improved efficiency and ultimately, better outcomes for patients.

The call to action is clear—to meet the challenges of today and tomorrow, pharmaceutical companies must invest in technology that enhances visibility, drives efficiency and helps ensure safety at every step. The future of pharma is digital and the time to implement these solutions is now.