Quality & Regulatory

From developing strategies to executing initiatives that deliver efficient and effective compliance, Excellis is ready to help. Excellis employs top consultants with diverse backgrounds and industry experience to provide clients with customized, value-added solutions and processes that enhance business efficiencies and minimize regulatory risk. We offer document and quality management platforms designed specifically for the pharmaceutical industry. Examples include:

  • Quality & Regulatory Audits
  • Document/SOP Reviews
  • Regulatory Readiness Activities
  • Regulatory agency response guidance and support
  • Quality Management Systems Strategy
  • Risk Evaluation
  • CAPA/Change management guidance and process improvement

Finally, Excellis is an expert in Software solutions with partnerships with top-tier vendors such as OpenText and VEEVA that lead the industry in supporting document control and quality management systems.

We maintain our strategies and initiatives through our Quality & Regulatory Mission Statement:

“Excellis is a dedicated team of professional consultants that aim to help bio-pharma companies transform and rationalize outdated and slow Quality Management, Manufacturing and Regulatory process to take full advantage of available technology to improve overall operational efficiency of customer organizations in support of faster drug development cycles.”

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