Services

OUR SERVICES

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Contract Manufacturing Services

Aseptic Fill-Finish

As a CDMO (Contract Development and Manufacturing Organization), AscentX Medical offers specialized aseptic fill and finish manufacturing services. Our expertise includes syringe filling, vial filling, and handling a variety of pharmaceutical and medical device products. We ensure the highest standards of quality and safety, meeting the stringent requirements of our clients and the FDA. Whether you need clinical-scale production or large-scale commercial manufacturing, our advanced facilities and experienced team are equipped to deliver exceptional results. If there is a service you need not listed here, please contact us to discuss your unique project requirements.

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Research and Development Support

AscentX Medical is committed to driving innovation through rigorous research and development. Our R&D support services encompass clinical trial material management, process development, and regulatory assistance. Our team of experienced scientists can help with formulation, method, and process development, ensuring that your projects are supported at every stage, from initial concept to regulatory approval.

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Quality Assurance and Compliance

Quality is at the core of AscentX Medical’s operations. Our comprehensive quality assurance and compliance services ensure that all products and processes adhere to stringent regulatory standards. From initial development to final production, we maintain the highest levels of quality and safety. Our commitment to excellence is reflected in our rigorous quality control measures and continuous improvement initiatives. Additionally, we offer assistance in developing product specific Standard Operating Procedures (SOPs), production batch records and related forms, ensuring that your processes are well-documented and compliant with industry standards and government agency regulations.

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Facilities

Our state-of-the-art facilities are designed to support a wide range of contract manufacturing and development needs. Equipped with ISO Class 5 sterile suites and ISO Class 8 clean rooms, we specialize in aseptic fill and finish processes, including syringe filling and vial filling. Our facilities are monitored 24/7 for security and environmental conditions, ensuring the integrity and quality of all products. Additionally, we offer qualified storage areas for USP controlled refrigerated and controlled room temperature conditions, as well as white glove-controlled shipping services to ensure products reach clinical sites in pristine condition.

Explore how AscentX Medical’s advanced capabilities and commitment to quality can support your unique projects. If there is a service you need not listed here, please contact us to discuss your specific requirements.