CDMO Services

Integrated CMC and manufacturing solutions for radiopharma­ceuticals

We take the lead in advancing global patient access to diagnostic and therapeutic radiopharma­ceuticals, delivering sponsors a full suite of radiopharma­ceutical process development with the Chemistry, Manufacturing, and Controls (CMC) expertise to support you from clinical phases through commercial manufacturing.

We provide integrated CMC capabilities spanning radiolabeling process development, radiochemistry and process design, analytical characterization, and scale-up from bench to cGMP and Annex-1 production. Supported by dedicated R&D infrastructure and expertise in quality systems, technology transfer, and radiopharma­ceutical logistics, our teams enable controlled, scalable development and successful commercialization.

Backed by decades of experience, our teams combine deep expertise in radiochemistry, quality systems, and logistics with a proven record of on-time, compliant manufacturing and distribution. We offer flexible solutions that adapt to each sponsor’s needs—accelerating development, ensuring reliable production, and enabling broader patient access.

Partnership Offerings

Radiolabeling Process Development
Radiochemistry & Process Design
Process Scale-Up from Bench to cGMP Manufacturing to Support Commercialization
Internal & External Technology Transfer
Analytical & Product Characterization
Dedicated Research and Development Personnel and Laboratory Spaces

Why Us?

Formulation Expertise for Process Scale-Up with Small Molecule, Peptide, and mAb Ligands
Radiosynthesis Automation Across Platforms Proven in the Real-World Manufacturing Environment
Analytical Method Development and Validation Expertise to the Highest Standards of Conventional Parenteral Drug Characterization with Deep Experience in Radiopharma­ceuticals
Supply of Radiopharma­ceuticals with Long-Lived Isotopes to Over 30 Countries

Our suite of offerings is supported by a collaborative team of scientists and regulatory professionals who have contributed to the development of more than 15 diagnostic and therapeutic radiopharma­ceuticals over the past four years, and to more than 40 technology transfer and regulatory submissions in 2025 alone, across 17 manufacturing sites worldwide.

Explore Our Other Services

CMO Diagnostics

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CMO Therapeutics

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Supply Chain & Radiopharmacy

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