SERVICE

GRAM Laboratories performs studies to support the Chemistry, Manufacturing and Controls (CMC) sections for development of a wide variety of dosage forms for small molecules, proteins, and peptides.  These studies include API and excipient qualification, preformulation evaluation, formulation development, analytical methods development and validation, stability studies of prototype batches leading to establishment of draft specifications, etc.  In addition, we perform routine monograph testing, quality control release testing, manufacturing process development support studies, and QA consultancy.  All studies are conducted with strict adherence to GLP and cGMP compliance so that study reports that are generated can be incorporated into regulatory submissions.

PHARMACEUTICAL

DEVELOPMENT

SERVICES