Congratulations!  Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it.  Take a moment… is your firm REALLY ready?  Your firm’s product is either starting its journey in a global supply chain or it is in the middle of a complex global supply chain.

Over the past three years, the pharmaceutical supply chain has undergone a profound transformation, driven by geopolitical tensions, cybersecurity threats, and regulatory imperatives.  Once considered a back-office function, assurance of supply chain resilience is now a strategic priority for pharmaceutical companies worldwide and outsourcing your firm’s accountability is not an option.

Geopolitical Risks Reshaping Global Routes

In 2025, the pharmaceutical supply chain is no longer defined by linear flows but instead by adaptive networks that are built for resilience.  Companies are embracing nearshoring strategies (New Release: Global Drug Supply Chain Diversification Alert White Paper), investing in digital infrastructure, and forging collaborative partnerships to withstand shocks—from armed conflicts to cyber intrusions.  The supply chain that your firm assessed in the previous decade may not be the same supply chain that it relies on today.

In this new era, supply chain excellence is not just about moving products, it’s about safeguarding global health against an unpredictable backdrop of risk.  Today’s risks include not only include the physical, such as temperature and storage conditions, but firms also need to consider vulnerability to counterfeiting, cybersecurity at transportation hubs, and port delays due to political decisions, such as tariffs.

According to the Dow Jones Pharmaceutical Risk Report: Supply Chain Central to Risk Landscape, supply-chain vulnerabilities are increasingly intertwined with geopolitical instability and cyber threats.  Conflicts in Ukraine and the Middle East coupled with fears of a potential escalation in the China-Taiwan conflict have disrupted traditional trade lanes.  Companies that once relied on predictable shipping routes through the Suez Canal or air corridors over Eastern Europe are now rerouting via longer, costlier paths such as the Cape of Good Hope.  These diversions add weeks to delivery timelines and inflate transportation costs, challenging the industry’s ability to maintain timely access to lifesaving medicines.

Regulatory Pressure and Risk Management

The EU Guidelines on Good Distribution Practice of medicinal products for human use | European Medicines Agency are clear on the expectations for controls required for distribution of product.  These guidelines mandate that transportation conditions must maintain product quality and integrity (which is demonstrated  by the integrity of supporting data).  A transport risk assessment aligned with ICH Q9(R1) is required, including considerations such as:

  • Delivery routes
  • Mode of transport (air, sea, road)
  • Environmental conditions (temperature, humidity, vibration)
  • Duration and number of transits

Is Your Risk Assessment Currently Protecting Product Quality?

The output of this process is expected to ensure compliance with GDP.  Another pressure on firms is the pressure to mitigate drug shortages (FDA Guidance for Industry: Risk Management Plans to Mitigate the Potential for Drug Shortages), which adds another layer of complexity to the process.  This draft guidance instructs manufacturers to anticipate vulnerabilities across the supply chain and implement proactive measures to prevent shortages of critical medicines.  With biologics and specialty drugs currently dominating pipelines, cold-chain integrity is paramount.  Temperature excursions already cost the industry an estimated $35 billion annually (The Pharmaceutical Supply Chain: Navigating Challenges, Regulatory Shifts, and Emerging Technologies | Pharmaceutical Outsourcing).

Lachman Consultants can help your firm to identify and mitigate these risks.  Don’t operate with blind spots; know the risks and manage them appropriately.  Reach out to us today for a consultation at LCS@LachmanConsultants.com.