Quality Processes with Exceptional Results
As a leader in the parenteral contract development and manufacturing industry, we deliver high-quality fill and finish services for clinical and commercial projects. Our expert project managers and growing, modern facilities support cGMP manufacturing, analytical testing and regulatory filing, with capabilities for small molecules, biologics and controlled substances.
Thanks to our superior industry knowledge, you can trust our team to provide exceptional client support, reliable processes, and quality results. We have a dedicated Continuous Improvement department that is focused on identifying and implementing improvements to our systems and processes that will ensure our ability to meet your needs in the most compliant, effective and efficient manner possible.
Trust and reliability are imperative in our industry, which is why all our team members are trained extensively on cGMP standards and technical requirements for handling important projects like yours. Additionally, we offer secure access for you to observe your product manufacturing during formulation and filling operations, offering you full transparency to the process, and confidence in the results.
From technology transfer to product delivery, and development to commercialization, you will have access to broad capabilities tailored to your specific needs. Our capabilities include:
- Aseptic processing
- Biologics and small molecule manufacturing
- Controlled substance manufacturing
- Formulation volumes up to 1,000 L
- High-speed filling with washer, depyrogenation tunnel and capper with 100% automated fill weight checks
- Commercial-scale lyophilization with automated loading/unloading and frozen shelf loading
- Single-use-systems, or product dedicated process equipment
- High-speed packaging with serialization and full aggregation
- Automated labeling with vision system
With every project, your dedicated project manager will listen to and assess your needs to develop compliant solutions that meet production requirements. Our continuous system reviews keep your project on target to reach your deadlines. During the process, we take a proactive approach to assessing risk and developing acceptable outcomes, providing documentation as support for audits. Learn more about our parenteral services and capabilities:
