As a CDMO providing biomanufacturing solutions to clients world-wide, we have the experience necessary to navigate ever-changing global cGMP requirements and ICH guidelines. We integrate our knowledge into every aspect of the development process, ensuring that the data generated by our analytical methods conforms to diverse regulatory specifications.
In addition to developing product specific methods, our staff has extensive experience in optimizing existing client methods, including qualification and validation.
Our analytical team and process development teams are integrated to ensure proactive data exchange, resulting in faster testing and seamless communication of results. This integrated approach allows for a faster, more efficient development process that truly accelerates your biologic program.