Facility and Quality Systems
Meeting the highest quality standards with a state-of-the-art cGMP facility
Our cGMP facility adheres to FDA 21 CFR Part 11 and Eudralex Vol. 4 Annex 11 compliant for ancillary material and drug substance production. Our work is supported by bioprocessing equipment supplied by industry-leading manufacturers, leveraging single-use upstream and downstream process trains for manufacturing along with fully equipped in-house process development and quality control labs to enable scale-up, technology transfer, method development, and reduced turnaround time on analytical testing.
Our quality program is supported by best-in-class electronic systems to exceed industry requirements
We’ve designed our quality systems and team to ensure quality throughout all stages of our services. Akron’s quality team is committed to working seamlessly with our clients and offers exceptional regulatory support on demand.
Our Sarasota facility features a full suite of analytical development and validation capabilities. We are committed to employing top-of-the-line equipment and systems under a cGMP-compliant quality management system (QMS) to ensure the quality and reliability of supply every time.
