GRAM Laboratories, Inc.
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.