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Why Drug Substance Shipping is not just Logistics?

Why Drug Substance Shipping is not just Logistics?

Wednesday, 20 August 2025

In the highly regulated world of pharmaceutical manufacturing, shipping drug substance is not simply moving material—it is recognized as a GMP-compliant extension of storage and the quality assurance process. 

At CARBOGEN AMCIS, we understand the unique challenges and responsibilities involved with controlled drugs substances pharmaceuticals transportation. The safety, integrity, and regulatory compliance of drug substances—especially controlled substances—must be preserved as rigorously during transit as during any in-house procedure. Here’s why our tailored shipping solutions make all the difference.

Tailormade Shipments, Reliable Processes


Every customer receives a tailor-made shipping solution for their specific drug substance, regulatory needs, and international requirements. Despite this personalization, our drug substances logistics remains consistent, reliable, and compliant; deviations in procedure are rare, thanks to our meticulous planning and robust process controls. Wherever your destination, our approach ensures traceability and smooth, timely delivery.

 

Proactive Route Planning and Challenge Anticipation

Shipping drug substances—especially controlled ones—requires thorough advance planning. Our team clarifies every detail ahead of time, from airport and route selection (critical for dry ice shipments), to the anticipation of delays or regulatory hurdles. This proactive approach is essential in drugs substances pharmaceuticals transportation, ensuring that every challenge is anticipated—not reacted to after the fact.

 

Incoterms, Responsibility, and Expert Support


Although our responsibilities may vary depending on the Incoterm, CARBOGEN AMCIS maintains support throughout the process. We engage personally in arranging shipping API drug substance across borders, and coordinate with qualified freight forwarders to guarantee final delivery.

 

Customs and Compliance: No Surprises


Efficient and compliant handling of export and import requirements is vital in controlled drugs substances logistics. We guarantee no shipment proceeds without confirmation of shipping paperwork from the importer of record, which significantly reduces the risk of customs delays. Our deep experience means customs are always under control, and compliance is ensured at every step.

            

Regulatory Focus: Shipping as Prolonged Storage

Industry authorities today scrutinize shipping drug substance as an extension of GMP-compliant storage. Shipping isn't just logistics—especially for controlled substances, it’s a regulated and absolutely critical step of the drug’s lifecycle. No matter how compliant your in-house production, all that assurance can be lost if the last metres of shipment do not meet the same high standards. During in-house processing, everything is under your control—so why risk quality and  compliance during shipping by lowering your standards in drug substances logistics?

 

Our Commitment: Excellence at Every Stage

CARBOGEN AMCIS recognizes the ever-growing regulatory expectations and challenges in controlled drugs substances pharmaceuticals transportation. To address them, we have established:

  • Efficient & Compliant Shipping: Strict adherence to GMP guidelines for all shipping drug substance projects.
  • Robust Supplier Qualification: Only working with audited, expert freight forwarders specialized in controlled drug substances logistics.
  • Experienced Teams: Staff with years of hands-on shipping drug substance experience and targeted annual training.
  • Meticulous Shipping Preparation: Qualified and validated packaging, courier confirmation, and solutions for dry ice refills at destination airports.
  • Strong International Network: Long-standing partnerships with premium logistics firms at strategic locations like Basel Airport, and with top thermal packaging suppliers.
  • Cutting-Edge Compliance: Deep experience in regulatory, import, and export compliance for pharmaceutical and controlled substances.
     

 

Shipping drug substance is not just a step in the supply chain, but a mission-critical phase supporting product quality, patient safety, and regulatory compliance. With CARBOGEN AMCIS, you gain a partner with proven expertise in drug substances logistics, guaranteeing security, continuity, and compliance across every shipment.



Do you have a Clinical or Commercial Drug Substance project?

Contact us now

 

For more information download our Clinical API Development brochure or contact us today.