About Clinical Trial Material Services
Maitland is a 14,000 sq. ft. US-FDA audited development and sterile manufacturing facility located in Orlando, Florida. Our labs were constructed with maximum flexibility in mind so that we can undertake and support novel drug projects. Our sterile suites and product lines caneasily, and cost effectively be customized to handle unique projects.
Our quality assurance program will guarantee that your product is manufactured and tested in full compliance with cGMP regulations. We have had multiple successful inspections by the US-FDA for compliance with cGMP regulations, with our most recent inspection occurring in March 2020.
Our quality systems include:
Comprehensive Quality Manual
24-hour environmental monitoring and controls with back up
GMP and SOP training
Post-manufacturing cleaning verification of all non-dedicated equipment
Complete audit of batch records and laboratory data for accuracy
Establishment of quality agreements with each client
At our US FDA inspected facilities, Maitland Labs specializes in sterile product manufacturing.We have decades of experience producing clinical trial materials (CTM) for both domestic andinternational clinical studies. In support of our development, testing and manufacturing of clinical supply materials, we ensure that all Maitland products include strict batch records, follow established standard operating procedure, and comply with cGMP protocols.