Inside today’s pharmaceutical supply chains: Risks, regulations, and real solutions

In pharmaceutical supply chains, life-saving products move through an impressively complex process with many key players and moving parts, spanning raw material suppliers, manufacturers, regulators, distributors, healthcare providers, and end customers. 

This process is tightly controlled and therefore leaves little to no room for error: At every stage, there’s an expectation of full traceability, strict temperature control, and adherence to evolving regulations like GDP, GMP, and ISO 13485 – plus a demand for speed and visibility that has only intensified. That’s exactly why pharma supply chains demand more accuracy and reliability than ever before, while maintaining costs under control. 

Let’s explore how this can be addressed – and find out more about the specific challenges of healthcare logistics.

Pharmaceutical supply chains are complex by default, as they involve multiple stakeholders, each responsible for ensuring that products remain safe, effective, and compliant from production through to delivery.

Here are four of the key challenges businesses in the sector face: 

From Good Manufacturing Practices (GMP) to Good Distribution Practices (GDP) and ISO 13485 for medical devices, regulatory requirements are high – and changing. 

Regulations vary between countries, which adds an extra layer of complexity for companies operating internationally. Staying compliant means putting robust processes in place, ensuring staff are trained, and maintaining full traceability and detailed records that regulators can audit at any time. Plus, non compliance risks not only fines, but also patient safety.

Many healthcare products are temperature-sensitive, where a deviation of just a few degrees can compromise their safety or effectiveness. Maintaining cold chain integrity, whether for 2°C to 8°C cold storage or ambient 15°C to 25°C conditions, requires validated equipment, continuous monitoring, and fast intervention when something goes wrong. 

Product diversion remains a significant risk in the pharmaceutical sector. To counter this, companies are required to implement serialisation and aggregation systems that track products at every stage, down to the smallest saleable unit. Effective traceability protects patients and also makes recalls easier to manage.

Supply disruptions, raw material shortages, and sudden spikes in demand can create gaps in availability, which most countries experienced at one point or another during the Covid-19 pandemic. 

At the same time, tight expiry dates mean products can quickly become unusable if healthcare supply chains lack the necessary agility. Striking the right balance – by keeping inventory levels high enough to meet demand but low enough to avoid excess and waste – is a constant challenge for organisations. 

In healthcare logistics, simplicity and control are key. That’s why FM Logistic has created its One Roof concept, an omnichannel approach designed to make pharma supply chains more efficient, flexible, and cost-effective.

One Roof is a multi-client, multi-activity omnichannel model where different healthcare businesses operate under the same roof, sharing space, resources, and services across storage, handling, and distribution operations.

For pharmaceutical companies, this approach brings several advantages:

By managing storage and distribution from a single location, companies can simplify their supply chains. The distribution of pharmaceuticals, medical devices, or even personal care products can be managed from one integrated site, making coordination simpler and faster.

Not all products require the same handling. FM Logistic’s One Roof concept ensures that each product type – whether it needs cold or frozen storage, or ambient conditions – is kept in its ideal environment. This avoids both over-specification and under-protection and helps maintain optimal product quality and integrity.

Pooling resources across multiple clients allows for economies of scale. Shared transport, consolidated warehouse space, and joint services help drive down costs without compromising on service or speed. In short, it provides a practical way to increase efficiency while maintaining flexibility in a highly regulated environment.

Working with a single logistics partner, under one contract, makes day-to-day management easier. There’s no need to juggle multiple suppliers or coordinate between different warehouses; FM Logistic acts as a single point of contact, helping clients maintain focus on their core activities.

To stay competitive, many organisations in the healthcare industry are turning to new technologies and strategies designed to enhance efficiency and resilience. Here are some of the key trends that are likely to shape the future of pharmaceutical logistics:

Warehouse automation helps improve speed, accuracy, and efficiency in pharma supply chains, be it with automated picking systems, robotics, or smart conveyor systems.

FM Logistic, for example, integrates Balea’s order-picking solutions, specifically designed for the pharmaceutical sector. These technologies improve accuracy, ensure full traceability, and help meet strict compliance requirements, particularly in tasks where precision and speed are critical.

With stricter regulations and the need for better risk management, end-to-end visibility has become essential. Serialisation and aggregation systems, combined with real-time data analytics, give companies a clearer picture of their supply chain, down to each individual unit.

Ideally, organisations need digital tools that offer full product traceability, enabling better inventory management, faster recalls, and stronger protection against counterfeit products. Tracking all relevant data helps ensure compliance – and also supports better decision-making.

Sustainability is a growing priority for pharmaceutical companies and their supply chain partners. Pooling strategies, energy-efficient warehouses, and low-emission transport are helping companies reduce their carbon footprints – for example, by consolidating shipments and optimising transport routes, companies can reduce the number of trucks on the road and lower fuel consumption.

Resilience is a core focus for the pharmaceutical sector. Whether it’s dealing with raw material shortages, geopolitical risks, or public health crises, companies need robust contingency plans to ensure uninterrupted supply.

FM Logistic’s dedicated Business Continuity Plan (BCP) referents work with clients to identify potential risks, develop mitigation strategies, and ensure that critical healthcare products reach their destinations, no matter the circumstances. 

Balancing strict compliance, temperature control, traceability, and cost efficiency demands more than just operational know-how – it requires working with a logistics partner with specialised healthcare expertise, robust processes, and a commitment to continuous improvement.

With over 15 years of experience in healthcare logistics, FM Logistic has developed a deep understanding of the challenges of the sector. Whether you need support managing regulatory requirements, ensuring cold chain integrity, or building resilience into your operations, we offer tailored, scalable solutions for fast, efficient, and sustainable logistics. 
If you’re looking to simplify and strengthen your pharmaceutical supply chain, our teams are here to help. Get in touch with our experts today.