We offer integrated oral solid dose services right from pre-formulation services to commercial manufacturing. Our expertise in chemistry helps our customer accelerate their NDA program by quick salt screening and supply of non-GMP Drug Substances (DS) and Drug Products (DP) for preclinical studies.
Cross-functional teams such as PK-PD, API synthesis, salt screening, toxicology, process engineering and analytical development teams are co-located and work in an integrated manner for efficient development. Continuous feedback among the teams at each stage of the life cycle helps resolve the issues during the early stage of NCE development and parallel activities help expedite the timelines for product delivery.
We also offer “Fit for purpose formulation” development for pre-clinical and FIH studies based on molecule pharmacokinetic behavior, excipient compatibility studies and screening of excipients.
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