Navigating Global Trade Challenges in Life Sciences and Healthcare Supply Chains

Navigating diverse and evolving regulations across markets (e.g. the U.S. Food and Drug Administration (FDA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA), formerly CFDA).

Staying compliant with Customs, HS code classification, import/export controls, sanctions and maximizing savings through Free Trade Agreements (FTAs).

Managing controlled substances and dual-use goods requiring special licenses.

Ensuring smooth market access in new geographies.

Establish a centralized regulatory knowledge base to track updates across all operating markets.

Standardize internal compliance checks and integrate them with your shipment planning processes.

Conduct regular audits of licenses and controlled substances management to prevent delays or penalties.

Train staff in evolving regulations to reduce the risk of error and strengthen organizational compliance.

Managing large volumes of documentation: certificates of analysis, import/export permits, health authority approvals, HS codes, and more.

Manual, fragmented processes, especially when dealing with multiple Customs brokers, can cause errors, fines, and delays.

Incomplete or incorrect documentation resulting in Customs delays, which, for temperature-sensitive products, can mean spoilage or unusable shipments.

Growing exposure to data compliance and digital security risks as sensitive documents are exchanged electronically.

Adopt standardized documentation templates and digital tools to streamline operations and reduce manual errors.

Work with specialized experts to manage broker interactions and standardize processes, minimizing compliance risks.

Conduct post-shipment reviews and audits to identify bottlenecks and drive continuous process improvements.

Partner with trusted healthcare supply chain providers that maintain strong digital security protocols and compliance frameworks to safeguard sensitive trade data

High duties and tariffs on medical devices, diagnostic equipment, and Active Pharmaceutical Ingredients (APIs).

Trade disputes and retaliatory tariffs that increase unpredictability and cost pressures.

Strict origin-tracking rules limiting flexibility in tariff engineering and FTA utilization.

Validate HS code classifications regularly (ideally once or twice per year) to minimize misclassification risks and unlock potential tariff savings.

Map your supply chain to understand rules of origin and how they apply to your goods.

Conduct scenario planning to model the potential financial impacts of tariff changes and trade disputes.

Seek advisory support from experienced Global Trade Management specialists to gain actionable insights for sourcing and manufacturing decisions.