Quality Assurance

Patient safety is the top priority in clinical drug development. Emerson Resources’ quality systems are designed and maintained to assure that our products meet the strict quality requirements of the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), and our customers. Our quality systems are evaluated for performance on a reoccurring basis as part of our commitment to continuous improvement.

Quality system highlights include an electronic Quality Management System (eQMS), enterprise-wide Chromatography Data Software (CDS), and Continuous Monitoring System (CMS).

Our facility is routinely audited by drug sponsors, Qualified Persons (QP), and the Drug Enforcement Agency (DEA).

Licenses and registrations:

Pennsylvania Dept. of Health Prescription and Non-Prescription Drug and Medical Device Manufacturer

DEA Manufacturer Registration #RE0276104

DEA Analytical Laboratory Registration #RE0405589

Contact us for more details.