Moravek offers cGMP quality assurance services, compliant with FDA cGMP guidance ICH Q7 Section 19, to ensure that your 14C-labeled API meets all regulatory requirements and obtains approval for use in clinical trials.
Moravek’s quality assurance team has over 30 years of experience in cGMP API manufacturing, so you can have utmost confidence in our products. Our cGMP quality assurance services are performed by a team of experts who design and implement comprehensive cGMP-compliant systems and standard operating procedures. These solutions consistently satisfy all necessary compliance activities including:
- Procurement
- Quarantine and release of reagents
- Manufacturing
- Isolation
- Quality control
- Chain of custody
- Temperature tracking
- Proper labeling and documentation
- Release
With our state-of-the-art facilities and highly trained staff, you can count on Moravek to deliver consistent and comprehensive cGMP quality assurance services for your custom 14C-labeled API. Our quality assurance team ensures that your API meets your specifications and is cGMP-compliant.
Our cGMP quality control solutions have successfully passed all client and regulatory body quality assurance inspections including cGMP inspections carried out by Merck and the California Department of Public Health. Moravek has passed all Quality Systems inspections and is approved to manufacture GMP 14C-labeled APIs for clinical trials.
If you have any questions about our services or procedures, contact our customer service team. We can’t wait to lend you a helping hand.