Our integrated group of scientists provides a seamless transition for API and drug substances from the initial discovery stages of the program to deeper process development. Our teams have extensive experience in route or step rebuild, process optimization and impurities assessment and synthesis.
We offer a full service of design, development and review of early stage analytical methods for assisting early stage dosage form development as well as the design, development and review of analytical method qualifications, preparing validation protocols and reports as per ICH / USFDA requirements. We provide full stability studies alongside our analytical and quality control teams.
Lyophilization cycles are not “one-size-fits-all,” and extensive cycle development is needed for each product. This includes a series of studies to understand the freezing and drying behavior of formulation components as well as investigations into how formulation strengths or containers affect the freeze-drying process. We specialise in niche scale lyophilization development.
We provide support and in-depth characterization expertise related to development and stability assessment of all types of oral solid dosage forms. We have comprehensive experience and competence within the dry powder inhalation field and have assisted in progressing inhalation projects.