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Muse clinical, quality assurance and compliance services

who we are

 

Auditors.  Quality Consultants.  Compliance Gurus.

 

We are a freelance consulting group providing quality assurance services to the pharmaceutical industry. 

 

We love the phrase “cooperative compliance” and believe that it truly represents our approach to quality.  We work with each of our clients to identify the best approach to achieve compliance and a practical path forward.  Each organization has a unique vision and culture and there is no “one size fits all” road to compliance. 

 

From an audit perspective, we recognize that quality is a cooperative effort and strive to convey to each site, vendor and division that we are “on the same side” during the audit process.  This encourages productive audits and builds upon relationships already in place with the auditee.  

what we offer

 

We pride ourselves on a risk-based and holistic approach to quality assurance and compliance, blending experience from years in the high-volume world of big pharma with a much-needed sensitivity to the culture of smaller organizations. 

 

Our services span the full range of quality assurance activities, allowing us to provide expert support to Sponsors, CROs and clinical investigators on a contract basis.

 

  • GCP auditing

  • Supplemental staff (director and manager levels)

  • Trial master file process and system development

  • Inspection readiness support

  • Risk assessment and mitigation strategy

  • Auditor training

  • SOP development and writing

  • Special projects and continuous improvement initiatives

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