Profile: Biosynergetics, Inc. provides biomedical & medical research and consulting resource specializing in biomedical engineering & pharmaceutical science. Our pharmaceutical/regulatory services include scientific document preparation/analysis or assessment, preparation & review of IND/NDA & other regulatory documents, FDA correspondence on matters other than standard submission documents, clinical study report preparation & submission, package insert preparation, dissolution & correlation analysis and dosage-form design & formulation development data. We also offer pharmacodynamic analyses including dose-effect & dose-response modeling and analytical assay methodology design & development.