With over 40 years of experience in labeled compound synthesis, Moravek is one of the most trusted contract manufacturing organizations offering synthesis and analysis of stable and 14C isotope labelled compounds in support of worldwide medical research and clinical trials.

Moravek has prepared over 250 carbon-14 labeled GMP APIs under license from the California Department of Health, Drug Manufacturing 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 FDA and EMA.

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

To meet the needs of our most risk averse GMP clients, Moravek has installed a Cummins 500kW 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 are 21 CFR part 11 compliant Agilent Enterprise Content Management system (ECM) and Rees Scientific automated Environmental Monitoring System (EMS).

We Welcome Remote and On-Site Quality Audits.

Our facilities, Quality System and operating procedures are continuously updated and improved through QA audits by leading pharma companies and government agencies.

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