Commitment to Quality

Xcelience has a strong quality record of success in meeting both regulatory agency and client standards.

Xcelience pharmaceutical development facilities have been regularly audited by both national regulatory agencies and client organizations.  As early as 2003 and 2006, Xcelience facilities were inspected by the United States Food and Drug Administration (FDA) with no 483s issued.  In 2008, Xcelience received our first pre-approval inspection resulting in client product approval.  In 2010, Xcelience hosted and completed more than 40 customer audits from companies 6 out of the top 10 pharma, specialty pharma, emerging pharma and virtual pharmaceutical companies.

Xcelience has received numerous Qualified Persons (QP) audits and certification to EU standards, in addition to regular inspections from the state of Florida.

Xcelience welcomes these audits as they ensure we are current with respect to industry trends and foster a culture of continuous improvement for our quality systems and operations.

Xcelience operates out of a cGMP compliant, DEA licensed facility in Tampa, Florida.

For more information on  Xcelience drug preformulation, analytical and stability, formulation development, clinical trial materials manufacturing, packaging and labeling , click “get a solution” above and one of our experts will contact you directly to discuss your specific needs.