Formulation Development and Clinical Manufacturing

We blend the art of formulation with advanced scientific tools to support drug product development from early stages through Phase 3, offering comprehensive manufacturing and regulatory services. It is often said that formulation is an art, not a science. Our art is supported by an extensive array of scientific tools that allow us to design and deliver formulations across a wide range of modalities, including immediate release, delayed release, extended release, osmotic/pulsatile drug delivery, sprinkle formulation, solution/suspension, and topical formulation. We support projects from toxicology through Phase 3 and beyond, including tech transfer to your commercial site. We can also assist in troubleshooting commercial formulation problems. Our state-of-the-art analytical services encompass method development, verification, and transfer. With cutting-edge equipment such as the Xcelodose X600S for precision capsule filling, the ACG Quest FB II for fluid bed processing, and a range of analytical instruments including automated hardness testers, disintegration apparatus, and moisture analyzers, we ensure unparalleled precision and efficiency at every step of the formulation process. We offer IND enabling, preclinical formulation, solid-state characterization, clinical formulation development, ICH stability studies, dissolution method development, and GMP-compliant clinical manufacturing. Additionally, we provide consultancy and authoring, as well as the review of the CMC technical elements of regulatory dossiers.