With over 45 years of experience, Moravek is one of the most trusted contract development and manufacturing organizations offering synthesis, purification, and analysis of radiolabeled, stable-labeled, and non-labeled compounds in support of worldwide medical research and clinical trials.

The team at Moravek has prepared over 100 14C-labeled good manufacturing practice (GMP) active pharmaceutical ingredients (APIs) under license from the California Department of Public Health - Food and Drug Branch. All of these APIs were on time for their study date, met release specifications, and were supplied with supporting documentation that met the requirements of regulatory agencies including the U.S. Food and Drug Administration and the European Medicines Agency.

Work with one of our highly experienced Proposal Development Coordinators to design an organized campaign that meets your specifications and all regulatory requirements. Then let a Project Manager provide proactive coordination for each stage of your campaign to facilitate on-time release of your API and a successful clinical trial.

To meet the needs of our most risk-averse GMP clients, Moravek has installed a Cummins 500-kW generator and is the first contract radiosynthesis facility to operate with 100% backup power to all operations.

Other examples of state-of-the-art GMP compliance include our Agilent Enterprise Content Manager (ECM) and Rees Scientific Environmental Monitoring System (EMS), both compliant with 21 CFR Part 11.

Reach out to Moravek to learn more about our GMP radiolabeling and custom synthesis services.

We Welcome Remote and On-Site Quality Audits.

In accordance with current good manufacturing practices, our facilities, Quality System, and operating procedures are continuously updated and improved through quality assurance (QA) audits by leading pharmaceutical companies and government agencies.

We look forward to tailoring a campaign to meet your QA and regulatory requirements. Read more about Moravek Quality.