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Cormica provides an unrivaled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical devices, healthcare, agrochemicals, biocides, food and feed sectors, including pesticides. We offer wide-ranging analytical and chemistry services to support the ANDA submission process for companies developing generic and complex generic products.
For successful commercialization of generic drugs, it is a prerequisite to demonstrate appropriate sameness and bioequivalence to the Reference Listed Drug (RLD). Cormica have significant experience in delivering solutions to support ANDA submissions, deploying specialized analytical techniques and synthetic chemistry expertise across multiple complex dosage forms.
We can support most aspects of Q1/Q2 (qualitative/quantitative equivalence of API and excipients), Q3 (physicochemical determinations to demonstrate the equivalent arrangement of microstructural matter) using an orthogonal array of analytical instrumentation and applications. We also deliver in vitro bioequivalence studies using appropriately validated methods and GMP-qualified instrumentation. Some examples include. MDRS, Spraytec and Next Generation Impactor IVBE studies for pulmonary dosage forms, polymorphic IVBE studies for suspension formulations by XRPD, DSC and FTIR and amorphous content/behavior studies using Isothermal Microcalorimetry.
Furthermore, our expertise in challenging synthetic chemistry is applied to generic development for the structural elucidation and identification of unknown impurities in the drug substance and prototype formulations using techniques such as NMR and semi-preparative mass-directed impurity isolation. Where necessary putative structures can also be synthesized.
We are MHRA and FDA-inspected and routinely develop, validate and transfer methods in support of ANDA submissions and beyond into QC release of drug substance, critical excipients and finished product.