In all of our development programs, we adopt a Quality by Design (QbD) approach, applying and challenging possible technologies and techniques in order to deliver the optimal product profile and performance in a timely and efficient manner.
We have capability for early stage API characterization, formulation, and analytical development through to process development, scale-up, and technology transfer for commercial manufacturing. We also support 505(b)(2) regulatory pathways. Our facilities and teams are designed to provide you the greatest flexibility while maintaining quality services.
We offer proven expertise in providing regulatory-compliant parenteral product development services for regulated and semi-regulated markets.