Moravek is an experienced contract manufacturing organization that offers custom cGMP API pharmaceutical manufacturing services including radiosynthesis, analysis, and radiochemical stability testing of carbon-14 labeled active pharmaceutical ingredients (APIs) for Phase 0 and Phase 1 clinical trials worldwide.
cGMP Carbon-14 Labeled API Pharmaceutical Manufacturing
As an API manufacturing company, our expertise in radiolabeling and strong quality culture contribute to our excellent track record. We have prepared over 100 14C APIs for use in clinical trials worldwide with 100% of our materials supplied on time with extensive documentation and meeting all regulatory requirements.
We are certified by the California Department of Health, Drug Manufacturing Branch for cGMP compliance and manufacture of carbon-14 labeled APIs suitable for Phase 0 and Phase 1 clinical trials.
All our custom cGMP API manufacturing services, including radiolabeling, analytical services, and stability study services, are performed in compliance with FDA ICH Q7 Section 19, Good Manufacturing Practice Guidance for the Synthesis of APIs for Use in Clinical Trials.
cGMP analytical and metrological data are generated and stored using validated equipment and 21 CFR Part 11 compliant data solutions from Agilent, Rees Scientific, Thermo Fisher, and Mettler Toledo. These data integrity compliance solutions are integrated throughout our state-of-the-art facilities including our four ISO Class 7 cleanrooms and our modern QC laboratory.
Each API is supplied with a complete analytical data package and batch record that are reviewed and approved by our independent QA department. Our API pharmaceutical manufacturing and documentation processes consistently provide cGMP compliance and assurance of quality that meets the requirements of regulatory agencies including the FDA and EMA.
To learn more about GMP 14C-labeled API manufacturing, contact a Moravek Proposal Development Coordinator and we will design an efficient radiolabeling campaign to meet your research needs and applicable regulatory requirements. Our highly experienced radiochemists may be able to suggest multiple feasible label positions so that you can select the label position that is most suitable for your study.
An expert Project Manager will provide proactive coordination for each stage of your campaign to facilitate on time supply of cGMP 14C API for a successful clinical trial.