LATITUDE’s formulation development services are responsive, time-line oriented and individually tailored to best meet its clients’ specific needs.
Our formulation development services, based on broad drug substance experience, cover the spectrum from preformulation, dosage form development through GLP toxicology (GLP tox) studies, and process development for cGMP manufacturing.
Our development capabilities include a full range of standard and proprietary formulations that include a broad array of oral, injectable, topical, inhalation, ophthalmic, depot and transmucosal delivery options for these and other routes of administration. We also specialize in GLP toxicology formulations to achieve the high exposure needed for these specialized studies.
LATITUDE’s analytical group operates in close association with our formulation group. This allows the rapid and seamless transfer and qualification of methods and the timely development and validation of new methods to meet any formulation development requirement.
LATITUDE provides expert services in the areas of process development, scale-up and technology transfer for cGMP manufacturing, services and materials sourcing, test method and specifications development and CMC document preparation for FDA submissions.