MVA Scientific Consultants is an FDA registered, DEA approved, and cGMP compliant analytical service lab. MVA provides microscopy, spectroscopy and litigation support for pharmaceutical and medical device companies; we specialize in foreign particulate identification, particle shape and size distribution analysis, drug polymorph characterization and morphology studies, nonconformance and root cause analysis, component distribution mapping, and delamination/corrosion studies. We can provide ongoing analytical support for all phases of drug development: the discovery phase, preclinical and clinical research, Food and Drug Administration (FDA) review, and post-marketing. We help manufacturers verify that their products meet the FDA’s specifications and guidelines to avoid and manage recalls. In the case of a product recall due to foreign particulate, MVA provides timely and reliable service support to help manufacturers identify the foreign particulate and determine the source of the contamination. Taking such preventive actions helps the manufacturers avoid a bigger loss of time and money and can help alleviate any regulatory concerns.
